—#83797

Product

Restoration Modular Hip System; Proximal Cone Body; 21 mm +20 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.

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: 6276-1-221; REST MOD PROX CONE BODY 21mm +20 28914301 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 28914301 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 28914301 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 28914301 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 28914303 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 28914303 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 29054901 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 29054901 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 29054901 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 29054901 13-Feb-2014 REST MOD PROX CONE BODY 21mm +20 28914302 20-Feb-2014 REST MOD PROX CONE BODY 21mm +20 29054903 10-Mar-2014 REST MOD PROX CONE BODY 21mm +20 29054902 25-Mar-2014 REST MOD PROX CONE BODY 21mm +20 28914302 20-Feb-2014 REST MOD PROX CONE BODY 21mm +20 29054902 25-Mar-2014 REST MOD PROX CONE BODY 21mm +20 29054902 25-Mar-2014 REST MOD PROX CONE BODY 21mm +20 29054902 25-Mar-2014 REST MOD PROX CONE BODY 21mm +20 29121502 25-Mar-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 #83797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.