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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66577

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

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Event summary

Timeline bucket
October 08, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes USA HQ, 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

Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

Z-0405-2014
Recall number
Z-0405-2014
Initiated
October 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
548

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

Code information

all lots of part no. 03.802.039

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada .