Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc.,

FDA device recall Z-1879-2008 · posted 2008-09-11 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KRO

Quantity affected

14 for all products.

Distribution

Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.

Date initiated

2008-05-15

Date posted

2008-09-11

Date terminated

2008-11-03

Location

Warsaw, IN

Related 510(k) clearances