ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
This recall has been terminated (originally issued October 22, 2010).
- Company
- Ebi, Llc
- Recall Initiated
- September 16, 2010
- Posted
- October 22, 2010
- Terminated
- June 1, 2012
- Recall Number
- Z-0131-2011
- Quantity
- 82 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
Lot / Code Info
Part number: 94672; Packaged lot number Product marked Lot # ( on device) 417400 415320 626740 624600 634130 629020
Root Cause
Other
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.