Z-2179-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- May 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
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
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
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