Recalls / —
—#104673
Product
Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads.
- 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
- K093644
- Affected lot / code info
- Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64) All Lots K093644
Why it was recalled
Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
Root cause (FDA determination)
Labeling False and Misleading
Action the firm took
The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Drive, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide distribution.
Timeline
- Recall initiated
- 2011-06-03
- Posted by FDA
- 2011-11-16
- Terminated
- 2013-11-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #104673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.