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Terminated

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

FDA Recall Z-0131-2011 · Posted 2010-10-22

Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeNKB
Date Initiated2010-09-16
Date Terminated2012-06-01
Product Quantity82 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution: USA and the countries of Australia, Columbia, Great Britain, The Netherlands, New Zealand, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062685EBI ARAY SPINAL SYSTEMEbi, L.P. · 2006-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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