RingLoc Bi-Polar Hip System Acetabular Cup recall
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Why was RingLoc Bi-Polar Hip System Acetabular Cup recalled?
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
- Recalling firm
- Biomet, Inc.
- Quantity
- 12 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
- Recall date
- July 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)