Recall Z-1273-06 ยท HWT Template
Zimmer Inc.
Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 10 mm diameter, 130 mm length, non-sterile, catalog no. 4309-10-13 (00-4309-010-13).
| Date | Jul 27, 2006 (initiated Jun 16, 2006) |
| Status | Terminated |
| Reason | During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal. |
| Root cause | Other |
| Action | U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem. |
| Quantity | 324 total |
| Distribution | Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.