FDA-Device2024-07-03Class II

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

Biomet, Inc.
Hazard

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

Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
Affected count
12 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2024

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