Z-1880-2008

Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet...

Name: Z-1880-2008 Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet...
Creator: Biomet, Inc.
Published: 2008-05-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-05-15 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of 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... on 2008-05-15. The reason FDA records is "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...". 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-1880-2008
Status: Terminated
Initiated: 2008-05-15
Posted: 2008-09-11
Terminated: 2008-11-03
Recalling firm: Zimmer GmbH
Product: 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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 14 for all products.
Distribution: Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.
Product codes and lots: Lots 354050, 138040 and 067490.

Product code KRO

K002757Class IIOncology Salvage SystemBiomet, Inc. / cleared 2000-11-24

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)