CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile recalled
Biomet is recalling REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile, distributed nationwide in the US. The recall was initiated on 5 Feb 2013 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-0925-2013
- FDA event ID
- 64354
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Feb 2013
- FDA classified
- 8 Mar 2013
- Reported
- 20 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 5 Feb 2013 | Recall initiated by company | |
| 8 Mar 2013 | Classified by FDA | +31 days |
| 20 Mar 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Where it was distributed
Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
Questions about this recall
Is REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile recalled?
Yes. Biomet recalled REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile on 5 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0925-2013.
Why was it recalled?
The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
Which lots are affected?
Catalog Number 5313152 Lot 153880,153930, 415500, 648010
Where was it sold?
Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and 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 21 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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