Device Recall METS

Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470

Orthopedic Devices

2

Yes

Directly distributed to TX, further distributed to AL and MS

METS SMILES Total Knee Replacement

A11290, A10107, A11828, A10610, A10765, A11439, A11922

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

B10191, B10443, B9920, B10561, B9921, B9922

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

B10635, B11820, B12776, B10636, B10638, B9866

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876

Orthopedic Devices

2

Yes

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone