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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71713

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

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Event summary

Timeline bucket
July 01, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes (USA) Products LLC

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 Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.

Z-2425-2015
Recall number
Z-2425-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
1487

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.

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

The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.

Code information

all lots of part numbers: 900.50, 900.51

Distribution pattern

Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.