—#107299

Product

OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K062997
Affected lot / code info: Lot numbers861280, 294060, and 723610

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands

Timeline

Recall initiated: 2012-02-07
Posted by FDA: 2012-03-02
Terminated: 2013-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.