Recall Z-1066-05 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Inc.
Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
| Date | Aug 3, 2005 (initiated Apr 15, 2005) |
| Status | Terminated |
| Reason | May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm. |
| Root cause | Other |
| Action | Consignees were notified via certified letter dated 4/6/05. |
| Quantity | 38 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953337 | BETA HIP PROSTHESIS Zimmer, Inc., Jan 22, 1996 |