Recall Z-0178-2010 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Zimmer Inc.
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.
| Date | Nov 12, 2009 (initiated Sep 17, 2009) |
| Status | Terminated |
| Reason | Some of the devices may possess a taper which will not mate with the humeral head, as intended. |
| Root cause | Other |
| Action | 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. |
| Quantity | 12 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041549 | ZIMMER TRABECULAR METAL HUMERAL STEM Zimmer, Inc., Sep 1, 2004 |