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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66421

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

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Event summary

Timeline bucket
July 31, 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

Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.

Z-0387-2014
Recall number
Z-0387-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
135

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

Code information

Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538

Distribution pattern

US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.