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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

DePuy Orthopaedics, Inc.: An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a

Agency Publication Date: December 20, 2012
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Affected Products

Product: SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mob

Product Code: 157215121 and Lot codes: 105800, 132795, 134667, AB8D51000, AB8D5A, AB8HE1000, AB8HE1A, AE3L11000, AF1EP1000, AF1EP1A, AF7KK1000, AV7JW1000, AW8F21000, AW8F2A000, BR4J81000, C15AN1000, C34B61000, C61CA1000, C77A81000, CE6FF1000, CE6FK1000, CG5B41000, CG5B41A, CK6BN1000, CK6BP1000, CK6BPA000, D32J41000, D46LD1000, D58EW1000, D74FB1000, DD3BP1000, DG1N71000, DH9JV1000, DH9JVA000, DW2A11000, E1RHD1000, E3SDC1000, E45LR1, E51E11, EB4MY1000, ED1DF1000, EH6B31000, ET4FG1000, EW7CD1000, FD4SW1, FJ9L71, and FK9D11.

Lot Numbers:
157215121
codes
Product: SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157215136 and Lot codes: 169458, AB8F51000, AF1ED1000, AF1EDA000, AF1EG1000, AF1EGA000, AF1EGB000, AF7KH1000, AV7JX1000, AW8F11000, BR4J91000, BT9FM1000, BT9FMA000, BT9FMB000, C1PC61000, C35D51000, C35D5A000, C3WCX1000, C4YBF1000, C5FH51000, C5FH5A000, C77A71000, C77A7B, CG5B51000, CH1AE1000, CH1AEA000, CH1AEB000, CH1AF1000, D1TLE1000, D3RFF1000, D46LE1000, D52LY1000, D5FDJ1000, D74ER1000, DA8MC1000, DD6E51000, DG1N81000, DN5HY1000, DS7KB1000, E1RHH1000, E1RHHA000, E3SDE1000, E45LS1, E5LCW1, E65NEA, EB6DJ1000, EC3DJ1000, EF8HJ1000, EK8JR1000, ES6CV1000, EW2HF1000, EY2EG1000, FE9P31, FG2F21, FJ9L81, and FK9D41.

Lot Numbers:
157215136
codes
Product: SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient m

Product Code: 157215150 and Lot codes: 111620, DD3BR1000, 126364, DD3BRA000, 134668A, DG1N91000, A37A71000, DN5H11000, A37A7A000, DN5H1B000, A37A7C, DT6ED1000, A3RBC1000, E1RHJ1000, A3RBCA000, E4HSE1000, A3YAV1000, E4LLG1000, A4VAK1000, E5EB41000, A6ACH1000, E5EB4A000, A88AA1000, E5WJ81000, AP2BB1000, E73B51, AV3DP1000, EC3DN1000, B2LAB1000, ED5KV1000, B3FAE1000, EJ4EG1000, B46AH1000, ER8EY1000, B54FC1000, EW6G31000, BS2GG1000, EY2ET1000, BY3BD1000, FB3E21, C1PC91000, FB8P81, C34B71000, FD4SX1, C3KA31000, FF8DT1, C4JCP1000, FG7DP1, C4VCP1000, FJ9L91, C5FH71000, X32EY1000, C5FH7A, X32EYA000, CC5JP1000, X32EYB000, CE6FL1000, X49FD1000, CH7EF1000, X49FDA000, CL5PE1000, X4ABK1000, CL5PE1A, X4ABKA000, CV5BS1000, X4ABKB000, CV5BSA000, X4GD91000, CX8CV1000, YA6GR1000, CX8CVA000, YF5DJ1000, CY7B11000, YH2C21000, D1TLF1000, YH2C2A000, D32J51000, Z41AS1000, D32J5A000, Z41ASA000, D37GC1000, Z5TH71000, D46LF1000, Z6BB81000, D52LX1000, Z6BB8A000, D81NN1000, Z83A11000, DA2EM1000, ZN7HS1000, DA2EMA000, ZN7HSA000, DA2EMB000, ZN7HSB000, and DA8MD1000.

Lot Numbers:
157215150
codes
Product: SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient

Product Code: 157215165 and Lot codes: 111621, FG9KT1, 126365, X3VB41000, A19GL1000, X4SC51000, A3XF31000, X4SC5A000, A3XF3A000, X4SC61000, A63GR1000, X53B11000, A6AE81000, X5REA1000, A6AE8A000, YF4AX1000, AY7KN1000, YF4AXA000, AY7KNA000, YG2CY1000, B19CJ1000, Z41AT1000, B3BJV1000, Z6BB91000, B3CAX1000, Z83BA1000, B65DF1000, Z83BAB000, B65DFA000, ZL9FW1000, C1YLX1000, ZL9FWA000, C34B81000, C34B8A000, C4JCR1000, C4JCRA000, C4VCR1000, C4VCRA000, CB2K71000, CH7ED1000, CK3EX1000, D32J61000, D46LG1000, D6DDD1000, D88H81000, DA2EN1000, DD3BS1000, DD3BSA000, DG1PA1000, DS7KC1000, E1KJ91000, E3SDG1000, E56BX1000, E5EB31000, FB3E31, FB8P91, FE9P41, and FG9KS1.

Lot Numbers:
157215165
codes
Product: SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient m

Product Code: 157215180 and Lot codes: 116897, 126366, A63GP1000, A63GPA000, AP2BD1000, B19CL1000, B19CLA000, B19CLC000, B3DE71000, B3DE7A000, B5CA41000, C1PDC1000, C4YBG1000, C4YBGB, CB1EX1000, CC5JR1000, CH1AC1000, CH7EG1000, CL5PF1000, DD3BT1000, DD3BTA000, DH9JW1000, E1KKA1000, EC8DY1000, ET4FH1000, FB8RA1, FG9KV1, X2HD31000, X2HD41000, X2HD4B000, X2HD4C000, X2HD4D000, X2HD51000, X2HD5A000, X5REB1000, X5REBB000, XY7F71000, YA6GS1000, YG3DE1000, YH8AK1000, YH8AKA000, and Z5VAP1000.

Lot Numbers:
157215180
codes
Product: SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient m

Product Code: 157215195 and Lot codes: 126367, A34FG1000, A63GS1000, B19HM1000, B3DE61000, B46AJ1000, BY6G81000, C4YBH1000, C5FH81000, CB9L21000, CH7EH1000, CP8NJ1000, D83FY1000, DG1PB1000, X24EW1000, X24EX1000, X24EY1000, X24EYB000, X3DC51000, X5SB31000, X5SB3A000, YA6GT1000, YF6AE1000, YF6AEA000, Z5VAN1000, and Z5VANB000.

Lot Numbers:
157215195
codes
Product: SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157225136 and Lot codes: AB8GM1000, AF7KD1000, AF7KE1000, AF7KEC, AF7KG1000, AV7JY1000, AV7JYA000, AW8FY1000, AW8FYA000, AW8FYD, BR4KA1000, C77A51000, C77A5A000, CK6BR1000, DW2A31000, DW2A3A000, E1KKB1000, E3RLJ1000, EE5M81000, EP3BH1000, and FJ2L81.

Lot Numbers:
157225136
codes
Product: SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased pati

Product Code: 157225150 and Lot codes: 107076, X4SE71000, 117308, X4SE7A000, A38B51000, X4SE7B000, AV3DR1000, YA9BN1000, B2DB11000, YF3E71000, BA4GR1000, YF3E7A000, BA4GRA000, YG4AF1000, BC4HR1000, Z47HE1000, C49A61000, Z4RJE1000, C6ACN1000, Z81H61000, C77A61000, CD1ER1000, , CD1ERA000, CK3E21000, CK3E2A, CY4GB1000, DX7J21000, DX7J2A000, E3FH61000, E4HB41000, E5DDA1000, E6BKR1, EJ4EH1000, EW9J61000, X32HH1000, X43C71000, X43C91000, and X43C9B000.

Lot Numbers:
157225150
codes
Product: SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157225165 and Lot codes: 105802, A19GM1000, A38B61000, B28JL1000, B2PAV1000, BB6KJ1000, C49A91000, C4JCS1000, C6ACS1000, CD1ET1000, CK3E71000, DH9JX1000, E3TF91000, E5LCS1000, EF1ES1000, FF8DW1, X32HF1000, X43DG1000, X4GEJ1000, X4GEK1000, X4GEM1000, X4GEMB000, X5RED1000, X78CM1000, YG1B51000, YG1B5A000, Z2HC31000, and Z81H71000.

Lot Numbers:
157225165
codes
Product: SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient

Product Code: 157225180 and Lot codes: B19HN1000, B19HNA000, B3FAF1000, BF6A21000, C32GEA, C5PRY1000, C61CD1000, CD1EW1000, EE5K61000, X33GC1000, X49FV1000, X4KF91000, X4KGA1000, X4KGB1000, X5SB41000, X5SB4A000, X5SB4B000, X5SB4C000, Y14GJ1000, Y14GJA000, YD3H31000, YD3HY1000, YG8B11000, YH9E21000, and YH9E2B000.

Lot Numbers:
157225180
codes
Product: SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157225195 and Lot codes: B2WBP1000, B34H81000, B34H8A000, BB1AJ1000, CD1EX1000, D5NEH1000, X4SF21000, X5FBT1000, X5FBTA000, X5FBV1000, X5FBVA000, X5PGM1000, X5PGN1000, X5PGNA000, X83KD1000, YF3E81000, YF6AF1000, YG4AG1000, ZA7JB1000, and ZA7JBA000.

Lot Numbers:
157225195
codes
Product: SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157225210 and Lot codes: C69C81000, X4BFN1000, X4SC81000, X57HS1000, X57HSA000, X5SB51000, YA9BP1000, YF3E91000, and YG3DF1000.

Lot Numbers:
157225210
codes
Product: SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157225225 and Lot codes: YF3FA1000 and YG9AW1000.

Lot Numbers:
157225225
codes
Product: SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased pati

Product Code: 157226136 and Lot codes: 126676, AB8GD1000, AB8GDA000, AF1EJ1000, AF1EK1000, AF1EKA000, AF1EKB000, AF7KF1000, AT4GJ1000, AT4GJA000, AW8FX1000, BR4KB1000, C4VCSA, C76FC1000, C82MV1000, D5LLL1000, D6DE51A, DG4FW1000, E5RKD1, E5RKDA, E79KF1, EJ4EJ1000, and FH8H6A.

Lot Numbers:
157226136
codes
Product: SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 1157226150 and Lot codes: 126677, B1PAN1000, B3PAH1000, B5CA51000, BE7J41000, BK1F11000, BP6CY1000, BP6CYA000, C61CE1000, CH7EE1000, CL5PH1000, CT8BF1000, D5NEJ1000, DA2EL1000, DA2ELA, E1VFG1000, E1VFGA000, E45LT1000, EL2EM1000, ES6CW1000, X5GB51000, X5HCE1000, X5SCC1000, X66BN1000, X83KE1000, YA6AF1000, YA6AFA000, YA6AFB, YD9EX1000, YG1B71000, Z5VJW1000, ZJ6FA1000, and ZL9FX1000.

Lot Numbers:
1157226150
codes
Product: SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased pati

Product Code: 157226165 and Lot codes: A46AN1000, B12LE1000, B12LEA000, B12LEB000, B3XAG1000, BP7E41000, C76FB1000, C82MW1000, CK3FJ1000, DD3BV1000, E12BV1000, E5WAY1000, EF1E41000, ER8L11000, FG7DR1, FJ9MB1, X57HV1000, X5HCC1000, X5PGR1000, X5PGS1000, X83KF1000, X83KFA000, YD9EY1000, YD9EYA000, YD9EYB000, YG1B81000, YG1B8A000, Z2HDE1000, Z2HDEA000, Z2HDEB000, Z5WFB1000, and Z5WFBB000.

Lot Numbers:
157226165
codes
Product: SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157226180 and Lot codes: 118843, A31E61000, B12LF1000, B2PAW1000, BC4HS1000, C5FH91000, C76FD1000, CK3FM1000, DG4FX1000, E6BKV1, ER8L21000, X34C41000, X49FG1000, X4SE81000, X4SE91000, X53B21000, YF4A61000, YF4A71000, YF4A7A000, YG4AH1000, YG4AHA000, YH9E51000, and YH9E5A000.

Lot Numbers:
157226180
codes
Product: SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien

Product Code: 157226195 and Lot codes: B2LAC1000, BN1K6A000, CE3FH1000, CL5PJ1000, X5GB61000, X5GB6A000, X5HCV1000, X5PGT1000, X5PGV1000, X5PGW1000, YF4A81000, YF5DP1000, YG7D61000, and Z41AV1000.

Lot Numbers:
157226195
codes
Product: SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient

Product Code: 157226210 and Lot codes: X43EX1000, X43EXA000, X43EY1000, X49FH1000, X4GDG1000, X57HX1000, and YH1ENA000.

Lot Numbers:
157226210
codes
Product: SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased pati

Product Code: 157226225 and lot code: YG9AX1000

Lot Numbers:
157226225
code

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 63545
Status: Resolved
Manufacturer: DePuy Orthopaedics, Inc.
Manufactured In: United States
Units Affected: 20 products (1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes; 1732 total all product codes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.