Device Recall Restoration Modular Hip System

Catalog number: 627601-027; REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069602 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069603 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069602 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069603 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081903 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29448101 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29448101 30-Mar-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Hip System; Proximal Cone Body; || 27 mm +0 mm (STD); || Not for use with + 16 V40 femoral Head. For 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: 6276-1-127;  REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28749101 19-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28932002 23-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28932002 23-Feb-2014 REST MOD PROX CONE BODY 27mm +10 28932002 23-Feb-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Hip System; Proximal Cone Body; || 27 mm +10 mm; || Not for use with + 16 V40 femoral Head. For 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: 6276-7-014; REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826A 27-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826F 29-Jan-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10E 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10E 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10E 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10A 19-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10A 19-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJ826C 17-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10C 20-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10C 20-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10C 20-Feb-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10D 05-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10D 05-Mar-2014 REST MOD CONICAL DISTAL STEM 14mmX155mm CAXJA10D 05-Mar-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular hip System, Conical Distal Stem, 14 mm x 155 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: 6276-7-015; REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910G 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910C 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910C 15-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910A 20-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910D 27-Jan-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909C 09-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827F 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827D 17-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909H 23-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909D 24-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909E 27-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909G 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909A 02-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909F 18-Feb-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910F 24-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910F 24-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ827C 13-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ909J 30-Apr-2014 REST MOD CONICAL DISTAL STEM 15mmX155mm CAXJ910E 31-Mar-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Hip System, Conical Distal Stem, 15 mm x 155 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: 6276-1-019; REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014 REST MOD PROX CONE BODY 19mm +0mm (STD) 29072201 10-Mar-2014

Orthopedic Devices

2

Yes

Worldwide Distribution

Restoration Modular Hip System; Proximal Cone Body; || 19 mm +0 mm (STD); || Not for use with + 16 V40 femoral Head. For 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.