Biomet, Inc.: Device Recall

Recall #Z-2179-2024 · 05/17/2024

Class II: Risk

Recall Details

Recall Number
Z-2179-2024
Classification
Class II
Product Type
Device
Recalling Firm
Biomet, Inc.
Status
Ongoing
Date Initiated
05/17/2024
Location
Warsaw, IN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Reason for Recall

41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention

Product Description

RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.