Z-0925-2013Class II

REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument

Name: Z-0925-2013 REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Creator: Biomet, Inc.
Published: 2013-02-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-02-05 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument on 2013-02-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0925-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-05
Posted: 2013-03-08
Terminated: 2013-09-30
Recalling firm: Zimmer GmbH
Product: REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Product code: LXH 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.
Root cause tag: manufacturing process
FDA 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 in commerce: 58
Distribution: Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
Product codes and lots: Catalog Number 5313152 Lot 153880,153930, 415500, 648010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0925-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0925-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)