Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; St
FDA device recall Z-0193-2012 · posted 2011-11-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 1677 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-06-03
- Date posted
- 2011-11-16
- Date terminated
- 2013-11-13
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTORATION ADM SYSTEM X3 ACETABULAR (K093644) | Howmedica Osteonics Corp. | 2009-12-18 |