Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Wa
FDA device recall Z-0178-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Some of the devices may possess a taper which will not mate with the humeral head, as intended.
- Action taken
- Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSD
- Quantity affected
- 12
- Distribution
- Nationwide.
- Date initiated
- 2009-09-17
- Date posted
- 2009-11-12
- Date terminated
- 2009-12-22
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER TRABECULAR METAL HUMERAL STEM (K041549) | Zimmer, Inc. | 2004-09-01 |