FDA Medical Device Recalls (openFDA)
Ebi, Llc: ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
- Recall number
- Z-0131-2011
- Recalling firm
- Ebi, Llc
- Product
- ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
- Status
- Terminated
- Initiated
- 2010-09-16
- Posted
- 2010-10-22
- Terminated
- 2012-06-01
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 82 units
- Distribution
- Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
- Lot, serial or model codes
- Part number: 94672; Packaged lot number Product marked Lot # ( on device) 417400 415320 626740 624600 634130 629020
- 510(k) numbers
- ["K062685"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 2242816
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28