Z-2213-2008

OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm...

Name: Z-2213-2008 OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm...
Creator: Biomet, Inc.
Published: 2007-11-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-11-07 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is... on 2007-11-07. The reason FDA records is "Mislabeled as to size: Product is labeled as reduced size, but is actually standard size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2213-2008
Status: Terminated
Initiated: 2007-11-07
Posted: 2008-09-17
Terminated: 2009-03-13
Recalling firm: Zimmer GmbH
Product: OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.
Quantity in commerce: 22
Distribution: Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.
Product codes and lots: Lots 053850, Exp 08/2016; 070890, Exp 08/2016; 201930, Exp 09/2016; 364790, Exp 10/2016; 507290, Exp 11/2016 and 534910, Exp 04/2017.

Product code KRO

K052685Class IIOrthopedic Salvage System- OssBiomet, Inc. / cleared 2005-10-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)