Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64354

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 05, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0925-2013
Recall number
Z-0925-2013
Initiated
February 05, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
58

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number 5313152 Lot 153880,153930, 415500, 648010

Distribution pattern

Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile