OSS AVL Poly Tibial Bushing Set recallZ-1143-2012 · Biomet, Inc. · initiated Feb 7, 2012
Terminated All recalls posted in March 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1143-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 7, 2012
- Posted by the FDA
- Mar 2, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 27 units distributed US and foreign
- Product code
- LZO
- FDA submissions
- K062997
- Distribution
- Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands
Product description
OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.
Code information (models, lots, serial numbers)
Lot numbers861280, 294060, and 723610
Other devices under the same FDA submission
2 devices cleared under K062997 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RingLoc® Hip System XL-108223Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
- RingLoc® Hip System XL-108323Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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