Recall Z-0210-2007 ยท HWT Template
Zimmer Inc.
Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
| Date | Nov 22, 2006 (initiated Oct 19, 2006) |
| Status | Terminated |
| Reason | The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal. |
| Root cause | Other |
| Action | The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer. |
| Quantity | 50 |
| Distribution | Nationwide and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.