Z-0131-2011

ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054

Name: Z-0131-2011 ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
Creator: Ebi, Llc
Published: 2010-09-16
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2010-09-16 / Terminated

FDA source

Ebi, Llc began a recall of ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054 on 2010-09-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0131-2011
Status: Terminated
Initiated: 2010-09-16
Posted: 2010-10-22
Terminated: 2012-06-01
Recalling firm: Ebi, LLC
Product: ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
FDA 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 in commerce: 82 units
Distribution: Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.
Product codes and lots: Part number: 94672; Packaged lot number Product marked Lot # ( on device) 417400 415320 626740 624600 634130 629020

Product code NKB

K062685Class IIEbi Aray Spinal SystemEbi, L.P. / cleared 2006-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)