Device Recall ULTIMALX STM

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

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

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. These stems were indicated for use with all DePuy bearings and acetabular cups.

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

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

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. These stems were indicated for use with all DePuy bearings and acetabular cups.

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

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

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. These stems were indicated for use with all DePuy bearings and acetabular cups.

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

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

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. These stems were indicated for use with all DePuy bearings and acetabular cups.

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

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

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. These stems were indicated for use with all DePuy bearings and acetabular cups.