Z-1143-2012

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

Name: Z-1143-2012 OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for...
Creator: Biomet, Inc.
Published: 2012-02-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-02-07 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures on 2012-02-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1143-2012
Status: Terminated
Initiated: 2012-02-07
Posted: 2012-03-02
Terminated: 2013-02-06
Recalling firm: Zimmer GmbH
Product: OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 27 units distributed US and foreign
Distribution: Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands
Product codes and lots: Lot numbers861280, 294060, and 723610

Product code LZO

K062997Class IIArcomxl Polyethylene Liners and 38/40Mm Femoral HeadsBiomet Manufacturing Corp / cleared 2006-12-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)