—#83786

Product

Restoration Modular Hip System; Proximal Cone Body; 21 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.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013106
Affected lot / code info: Catalog number: 6276-1-021; REST MOD PROX CONE BODY 21mm +0mm (STD) 28733303 22-Jan-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733303 22-Jan-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28733301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800301 09-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847903 11-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847903 11-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847901 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28847902 16-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 28800302 17-Feb-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299401 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29299402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358402 23-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29476201 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29476201 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29492001 27-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29285601 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29421001 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29421001 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29358401 30-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29285601 31-Mar-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29524901 07-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29546101 08-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014 REST MOD PROX CONE BODY 21mm +0mm (STD) 29706302 21-Apr-2014

Why it was recalled

The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-06-26
Posted by FDA: 2009-09-14
Terminated: 2010-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.