Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill Co
FDA device recall Z-0884-2009 · posted 2009-01-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker became aware of a lot for lot mix up.
- Action taken
- Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 4
- Distribution
- Class II Recall - Nationwide Distribution
- Date initiated
- 2008-11-21
- Date posted
- 2009-01-26
- Date terminated
- 2012-06-25
- 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 MODULAR SYSTEM (K022549) | Howmedica Osteonics Corp. | 2002-09-23 |