FDA Enforcement
Class II
Ongoing
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Recall: Z-2179-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2179-2024
- Event ID
- 94742
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2024
- Initiation Date
- May 17, 2024
- Classification Date
- June 25, 2024
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989, United States
Description
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
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 Info
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
Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
Quantity
12 units