Z-0925-2013 Class II Terminated
FDA device recall Z-0925-2013 was initiated by Biomet, Inc. on Feb 5, 2013 and is designated Class II. 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… The recall status is terminated (terminated Sep 30, 2013). Affected quantity: 58.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2013
- Initiation Date
- Feb 5, 2013
- Termination Date
- Sep 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58
Product Description
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
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.
Distribution Pattern
Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
Code Information
Catalog Number 5313152 Lot 153880,153930, 415500, 648010
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0925-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026