Device Recall SIGMA

All lots

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of : Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.

(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706

Lot Y88D14.

Orthopedic Devices

2

Yes

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.

Lot Y88D64.

Orthopedic Devices

2

Yes

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.

Lots X23AD4 and X23AE4.

Orthopedic Devices

2

Yes

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.

Lot Y88D94.

Orthopedic Devices

2

Yes

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.