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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66415

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

Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.

Z-0384-2014
Recall number
Z-0384-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
634

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.

Code information

Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635

Distribution pattern

Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.