DePuy Orthopaedics, Inc.: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U

Agency Publication Date: June 29, 2012

Affected Products

Product: ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. The

Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.

Lot Numbers:

853151and

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. The

Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.

Lot Numbers:

853151and

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. T

Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.

Lot Numbers:

853153

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty.

Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21

Lot Numbers:

853154

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. The

Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.

Lot Numbers:

853155

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. Thes

Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12

Lot Numbers:

853156

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. Thes

Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.

Lot Numbers:

853157

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. Thes

Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25.

Lot Numbers:

853158

numbers

Product: ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. Thes

Product code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43.

Lot Numbers:

853159

numbers

Product: LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.

Lot Numbers:

152180001

numbers

Product: LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.

Lot Numbers:

152180002

numbers

Product: LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.

Lot Numbers:

152180003

numbers

Product: LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000.

Lot Numbers:

152180004

numbers

Product: LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.

Lot Numbers:

152180005

numbers

Product: LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180006 and Lot numbers: A21BR1000, A4CD61000, AR1C81000, BB8E31000, V2RCB1005, W4GCP1007, WR6EXA000, WS3GX1003, X5SFN1000, X68GE1000, Y47BLA000, Y4HA21000, Z1TD71000, and Z66H41000.

Lot Numbers:

152180006

numbers

Product: LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.

Lot Numbers:

152180007

numbers

Product: LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000.

Lot Numbers:

152180008

numbers

Product: LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000.

Lot Numbers:

152180009

numbers

Product: LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.

Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007.

Lot Numbers:

152180010

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61749

Status: Resolved

Manufacturer: DePuy Orthopaedics, Inc.

Manufactured In: United States

Units Affected: 19 products (431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots; 85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Affected Products

Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.

Lot Numbers:

853151and

numbers

Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.

Lot Numbers:

853151and

numbers

Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20.

Lot Numbers:

853153

numbers

Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21

Lot Numbers:

853154

numbers

Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74.

Lot Numbers:

853155

numbers

Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12

Lot Numbers:

853156

numbers

Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07.

Lot Numbers:

853157

numbers

Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25.

Lot Numbers:

853158

numbers

Product code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43.

Lot Numbers:

853159

numbers

Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.

Lot Numbers:

152180001

numbers

Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.

Lot Numbers:

152180002

numbers

Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.

Lot Numbers:

152180003

numbers

Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000.

Lot Numbers:

152180004

numbers

Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003.

Lot Numbers:

152180005

numbers

Product code:152180006 and Lot numbers: A21BR1000, A4CD61000, AR1C81000, BB8E31000, V2RCB1005, W4GCP1007, WR6EXA000, WS3GX1003, X5SFN1000, X68GE1000, Y47BLA000, Y4HA21000, Z1TD71000, and Z66H41000.

Lot Numbers:

152180006

numbers

Product code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.

Lot Numbers:

152180007

numbers

Product code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000.

Lot Numbers:

152180008

numbers

Product code:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000.

Lot Numbers:

152180009

numbers

Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007.

Lot Numbers:

152180010

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61749

Status: Resolved

Manufacturer: DePuy Orthopaedics, Inc.

Manufactured In: United States