Device Recall Restoration Modular Proximal Broached Body

Catalog number: 6276-7-114; REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834D 22-Dec-2013 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834D 22-Dec-2013 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834C 23-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834E 23-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834E 23-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834E 23-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29C 29-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29C 29-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29D 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29E 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29E 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834F 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29E 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834F 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29E 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834F 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834G 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834G 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834G 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834H 02-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834H 02-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834H 02-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJ834G 05-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX195mm CAXJA29F 03-Apr-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Hip System, Conical Distal Stem, 14 mm x 195 mm; Straight, Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.

Catalog number: 6276-3-005; REST MOD PROX BROACHED BODY SIZE #5 28916701 27-Jan-2014 REST MOD PROX BROACHED BODY SIZE #5 28916701 27-Jan-2014 REST MOD PROX BROACHED BODY SIZE #5 28916701 27-Jan-2014 REST MOD PROX BROACHED BODY SIZE #5 28943701 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #5 28916701 27-Jan-2014 REST MOD PROX BROACHED BODY SIZE #5 28943701 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #5 28943701 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #5 28943701 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #5 29706001 20-Apr-2014 REST MOD PROX BROACHED BODY SIZE #5 29706001 20-Apr-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Proximal Broached Body, Size 5; || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.

Catalog number 6276-3-006; REST MOD PROX BROACHED BODY SIZE #6 28962801 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #6 28962801 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #6 28962801 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #6 28962801 11-Feb-2014 REST MOD PROX BROACHED BODY SIZE #6 28962801 11-Feb-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Proximal Broached Body, Size 6; || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.

Catalog number:6276-3-008; REST MOD PROX BROACHED BODY SIZE #8 29137703 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137701 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137701 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137701 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137703 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137703 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137703 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137703 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29137701 12-Feb-2014 REST MOD PROX BROACHED BODY SIZE #8 29389202 18-Mar-2014 REST MOD PROX BROACHED BODY SIZE #8 29389202 18-Mar-2014 REST MOD PROX BROACHED BODY SIZE #8 29389601 19-Mar-2014 REST MOD PROX BROACHED BODY SIZE #8 29389601 19-Mar-2014 REST MOD PROX BROACHED BODY SIZE #8 29389601 19-Mar-2014 REST MOD PROX BROACHED BODY SIZE #8 29389601 19-Mar-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Proximal Broached Body, Size 8; || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.