FDA Device recall Z-0925-2013
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument by Biomet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0925-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-05 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | n/a |
Product
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Reason
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.
Identifiers
| code_info | Catalog Number 5313152 Lot 153880,153930, 415500, 648010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0925-2013%22
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