ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
FDA device recall Z-0131-2011 · posted 2010-10-22 · Terminated
Recall details
- Recalling firm
- Ebi, Llc
- Reason for recall
- One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability.
- Action taken
- Biomet Spine issued an Urgent Medical Device Recall letter dated September 16, 2010 to distributors and physicians, identifying the affected device and actions to be taken. Customers and distributors were requested to identify, remove, and immediately return the affected product to Biomet, following enclosed Product Return Instructions, and complete and return the Removal Tracking and Verification Form. Customers and distributors can contact Biomet at 1-800-526-2579.
- Root cause
- Other
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 82 units
- Distribution
- Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
- Date initiated
- 2010-09-16
- Date posted
- 2010-10-22
- Date terminated
- 2012-06-01
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EBI ARAY SPINAL SYSTEM (K062685) | Ebi, L.P. | 2006-10-06 |