Skip to content

Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm… recallZ-1880-2008 · Biomet, Inc. · initiated May 15, 2008

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--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.

FDA root cause category: Labeling False and Misleading

What the company is doing

On May 15, 2008 an Urgent Medical Device Removal Notice was issued to consignees and implanting physicians notifying them to return the product and of risks involved, respectively. Any adverse reactions which may be experienced with the use of this product should be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852, or the MedWatch website at www.fda.gov/medwatch. If you have any questions contact Mary Hardesty, Manager, Corrective Actions, Biomet Orthopedics, Inc. at 1-800-348-9500.

Recall details

Recall number
Z-1880-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 15, 2008
Posted by the FDA
Sep 11, 2008
Recalling firm
Biomet, Inc.
Quantity
14 for all products.
Product code
KRO
FDA submissions
K002757
Distribution
Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.

Product description

Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement knee joint.

Code information (models, lots, serial numbers)

Lots 354050, 138040 and 067490.

Other devices under the same FDA submission

59 devices cleared under K002757 — 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 48633).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page