Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
FDA device recall Z-1066-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
- Action taken
- Consignees were notified via certified letter dated 4/6/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 38
- Distribution
- Nationwide and Canada.
- Date initiated
- 2005-04-15
- Date posted
- 2005-08-03
- Date terminated
- 2005-08-11
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BETA HIP PROSTHESIS (K953337) | Zimmer, Inc. | 1996-01-22 |