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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69753

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

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Event summary

Timeline bucket
November 06, 2014
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 Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.

Z-0931-2015
Recall number
Z-0931-2015
Initiated
November 06, 2014
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.

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

The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.

Code information

All lots of part number 05.001.175, lot numbers: 28, 40, 41, 42, 53, 105, 107, 111, 112, 113, 115.

Distribution pattern

US Nationwide Distribution to Florida only