RingLoc Hip Acetabular Cup Recalled for Assembly Defect
Biomet recalled RingLoc hip acetabular cup components that may have been incorrectly assembled with a mismatched locking ring, potentially causing joint instability. Affected patients may require surgical intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a structural assembly defect (mismatched locking ring) that poses risk of joint instability requiring surgical intervention. No injuries or hospitalizations have been reported; this is a preemptive recall for a potential hazard.
Plain-English summary
Biomet, Inc. is recalling RingLoc Bi-Polar Hip System Acetabular Cup components (41 mm outer diameter, item number 11-165206) used in hip hemi-arthroplasty. The recall affects 12 units with distribution in the United States (Arizona, California, New Jersey, Pennsylvania, Texas, and Virginia) and Chile.
The recalled units may have been incorrectly assembled with a 42 mm locking ring instead of the correct size. This mismatch between the 41 mm acetabular cup and the 42 mm locking ring could cause joint instability in the implanted hip.
Joint instability may require surgical intervention to address. Patients who have received hip implants using affected components should contact their surgeon or physician immediately. The recalled lot numbers are: 66540443, 66601057, 66623486, and 66635486.
The recalled product
- Product
- RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
- Manufacturer
- Biomet, Inc.
- Hazard
- assembly-defect
- joint-instability
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
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