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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69974

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2014
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
The Anspach Effort, 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 Small Electric Drive (SED)

Z-1017-2016
Recall number
Z-1017-2016
Initiated
November 14, 2014
Classification
Class II
Status
Ongoing
Recalling firm
The Anspach Effort, Inc.
Quantity
302 (23 in the USA and 279 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.

Code information

All lots from production launch

Distribution pattern

CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.