Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 B
FDA device recall Z-0190-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Zimmer Spine, Inc.
- Reason for recall
- Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.
- Action taken
- Distributors were notified via email with an Urgent Product Recall letter beginning 10/12/2006. Distributors are to return their own inventory and any hospital consignment inventory by October 20, 2006. A Certification Form is also to be faxed back to Zimmer Spine.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 159
- Distribution
- Nationwide and Japan
- Date initiated
- 2006-10-05
- Date posted
- 2006-11-16
- Date terminated
- 2007-10-29
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ST360 SPINAL FIXATION SYSTEM (K041925) | Zimmer Spine, Inc. | 2004-09-24 |
| CADENCE SPINAL FIXATION SYSTEM (K022374) | Sulzer Spine-Tech | 2002-09-24 |