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OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial… recallZ-2213-2008 · Biomet, Inc. · initiated Nov 7, 2007

Terminated All recalls posted in September 2008

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-2213-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 7, 2007
Posted by the FDA
Sep 17, 2008
Recalling firm
Biomet, Inc.
Quantity
22
Product code
KRO
FDA submissions
K052685
Distribution
Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

3 devices cleared under K052685 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 45806).

Sources and updates

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