Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc.,
FDA device recall Z-0525-2010 · posted 2009-12-14 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which could result in a weakening of the strength of the metal.
- Action taken
- Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 13
- Distribution
- Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
- Date initiated
- 2009-09-21
- Date posted
- 2009-12-14
- Date terminated
- 2010-10-08
- 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 |
|---|---|---|
| SPEEDLINK TRANSVERSE CONNECTOR (K002082) | Spinal Concepts, Inc. | 2000-10-06 |