CLASS II ONGOING Device recall · Reported 3 Jul 2024 · FDA Enforcement Report
RingLoc Bi-Polar Hip System Acetabular Cup Outer Diameter recalled
Biomet is recalling RingLoc Bi-Polar Hip System Acetabular Cup Outer Diameter - Used in hip hemi-arthroplasty, distributed nationwide in the US. The recall was initiated on 17 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2179-2024
- FDA event ID
- 94742
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 May 2024
- FDA classified
- 25 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 17 May 2024 | Recall initiated by company | |
| 25 Jun 2024 | Classified by FDA | +39 days |
| 3 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
Nationwide ArizonaCaliforniaNew JerseyPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
Which lots 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
Where was it sold?
Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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