Device product

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

Z-2179-2024

May 17, 2024

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 94742
Status: Ongoing
Classification: Class II
Quantity: 12 units
Official record key: device-enforcement:Z-2179-2024

Official wording

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

Code information: Lot Number / UDI Number (1) 66540443 (01)00880304001923(17)290408(10)66540443; (2) 66601057 (01)00880304001923(17)290405(10)66601057; (3) 66623486 (01)00880304001923(17)290327(10)66623486; (4) 66635486 (01)00880304001923(17)290327(10)66635486

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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