FDA Medical Device Recalls (openFDA)
Biomet, Inc.: REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
- Recall number
- Z-0925-2013
- Recalling firm
- Biomet, Inc.
- Product
- REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
- Status
- Terminated
- Initiated
- 2013-02-05
- Posted
- 2013-03-08
- Terminated
- 2013-09-30
- 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.
- Root cause
- Process control
- Action
- BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676.
- Quantity
- 58
- Distribution
- Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
- Lot, serial or model codes
- Catalog Number 5313152 Lot 153880,153930, 415500, 648010
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28