Recall Z-2179-2024— Biomet, Inc.
Class II · Ongoing
Class II FDA medical device recall by Biomet, Inc., initiated 2024-05-17. It names one FDA 510(k) clearance: K051569. Product: 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.
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-17
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.