Biomet, Inc.: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Agency Publication Date: July 11, 2013

Affected Products

Product: REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M619730 , M480920, M656920, M938460, M444630

Product: REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M619740, M492940, M444640, M656930, M938470

Product: REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M879630 , M584360, M492950, M444650, M656940, M938480

Product: REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M879640, M375460, M444660, M886350, M938490

Product: REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M375470, M444680 , M886360, M938500

Product: REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M561220 M584370 M151880 , M444690, M886370 , M956050,

Product: REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M619750 ; M375480; M886380, M956060 , M444700

Product: REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M561290, M956070, M444710 6, M136780, M886390

Product: REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M375490, M444720 , M886400, M956080

Product: REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M375500 ,M886410, M444760, M956090

Product: REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M321570, M894590,M619770, M480930, M656950 M444780, M969100

Product: REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M321580 , M619780, M492960, M656960, M969120 , M444790 6

Product: REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M539400, M619790, M987360 , M444800, M969130, M151150, M987360

Product: REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M492970, M598310, M598310, M656980, M969150

Product: REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M584380, M754830, M969160, M444820, M987510

Product: REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M987290, M035670, 987410, M444830, M920680, M754840

Product: REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M598320, M480940, M987300, M444840, M656990

Product: REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M300790, M632920, M539410, M444850, M987620, M987310

Product: REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M632930 , M539420 , M444860 , M657010, M987630 , M987320

Product: REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640

Product: REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640

Product: REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M561240, M632960 , M136950 M657040 , M722420 , M444890

Product: REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M480950 , M657050, M444900 , M030220

Product: REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M321600, M539430, M444910, M657070,M722440, M136980, M444910

Product: REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M921180, M539440, M444920, M722450, M136990, M657080

Product: REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M632970 , M539450 , M920610 , M657090 , M017520 , M166860 , M886420

Product: REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M632980 , M539460 , M657100 , M017530 , M166870 , M920620 , M886430

Product: REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M561250, M657110, M017540, M166880, M920640, M886440

Product: REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M480960, M657120, M886450, M166890, M920650

Product: REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

M492980, M657130, M920670, M886460, M166900

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65459

Status: Resolved

Manufacturer: Biomet, Inc.

Manufactured In: United States

Units Affected: 30 products (26; 22; 28; 30; 22; 25; 24; 23; 22; 22; 32; 30; 23; 24; 20; 29; 37; 46; 26; 26; 25; 25; 25; 28; 31; 26; 25; 23; 25; 24)

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Sources: FDA iRES · Raw API Response

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Affected Products

M619730 , M480920, M656920, M938460, M444630

M619740, M492940, M444640, M656930, M938470

M879630 , M584360, M492950, M444650, M656940, M938480

M879640, M375460, M444660, M886350, M938490

M375470, M444680 , M886360, M938500

M561220 M584370 M151880 , M444690, M886370 , M956050,

M619750 ; M375480; M886380, M956060 , M444700

M561290, M956070, M444710 6, M136780, M886390

M375490, M444720 , M886400, M956080

M375500 ,M886410, M444760, M956090

M321570, M894590,M619770, M480930, M656950 M444780, M969100

M321580 , M619780, M492960, M656960, M969120 , M444790 6

M539400, M619790, M987360 , M444800, M969130, M151150, M987360

M492970, M598310, M598310, M656980, M969150

M584380, M754830, M969160, M444820, M987510

M987290, M035670, 987410, M444830, M920680, M754840

M598320, M480940, M987300, M444840, M656990

M300790, M632920, M539410, M444850, M987620, M987310

M632930 , M539420 , M444860 , M657010, M987630 , M987320

M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640

M561240, M632960 , M136950 M657040 , M722420 , M444890

M480950 , M657050, M444900 , M030220

M321600, M539430, M444910, M657070,M722440, M136980, M444910

M921180, M539440, M444920, M722450, M136990, M657080

M632970 , M539450 , M920610 , M657090 , M017520 , M166860 , M886420

M632980 , M539460 , M657100 , M017530 , M166870 , M920620 , M886430

M561250, M657110, M017540, M166880, M920640, M886440

M480960, M657120, M886450, M166890, M920650

M492980, M657130, M920670, M886460, M166900