OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.
FDA Recall Z-1143-2012 · Posted 2012-03-02
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2012-02-07
Date Terminated2013-02-06
Product Quantity27 units distributed US and foreign
Reason for Recall
Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.
Firm Action
BIOMET Orthopedics sent an URGENT MEDICAL DEVICE recall notice dated February 7, 2012, to all affected consignees. The recall notice instructed consignees to immediate locate and remove the devices from circulation and to fax back the response form to 574-372-1683. If product was further distributed, consignees must notify hospital personnel of this action via the enclosed notice. Consignees were charged with the location and return of the affected product.
For questions regarding this recall call 574-372-3983 or 574-371-3009.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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