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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65560

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

Open FDA event record

Event summary

Timeline bucket
June 11, 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 Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

Z-1952-2013
Recall number
Z-1952-2013
Initiated
June 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
13,050

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.

Code information

All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115

Distribution pattern

Nationwide Distribution.