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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76182

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

Open FDA event record

Event summary

Timeline bucket
December 29, 2016
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 Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.

Z-1124-2017
Recall number
Z-1124-2017
Initiated
December 29, 2016
Classification
Class II
Status
Terminated
Quantity
50,311 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

Code information

Part Numbers: 03.402.006 03.402.007 03.402.008 03.402.009 03.402.010 03.402.018 03.402.020 03.402.022 03.402.024 03.402.026 03.402.028 03.402.106 03.402.107 03.402.108 03.402.109 03.402.110 03.402.218 03.402.220 03.402.222 03.402.224 03.402.226 03.402.228 03.402.418 03.402.420 03.402.422 03.402.424 03.402.426 03.402.428 03.402.618 03.402.620 03.402.622 03.402.624 03.402.626 03.402.628 03.402.701 03.402.710 03.402.711 03.402.712 03.402.716 03.402.717 03.402.718 03.402.719 03.402.720 03.402.721 03.402.722 03.402.723 03.402.724 03.402.725 03.402.726 03.402.727 03.402.728 03.402.729 03.402.730 03.402.731 03.402.732 03.402.733 03.402.734 03.402.735 03.402.740 03.402.741 03.402.744 04.402.006S 04.402.007S 04.402.008S 04.402.009S 04.402.010S 04.402.026S 04.402.027S 04.402.028S 04.402.029S 04.402.030S 09.402.018S 09.402.020S 09.402.022S 09.402.024S 09.402.026S 09.402.028S 09.402.218S 09.402.220S 09.402.222S 09.402.224S 09.402.226S 09.402.228S 09.402.418S 09.402.420S 09.402.422S 09.402.424S 09.402.426S 09.402.428S 09.402.618S 09.402.620S 09.402.622S 09.402.624S 09.402.626S 09.402.628S 60.402.001 60.402.002 61.402.001 01.402.001E

Distribution pattern

United States Nationwide Distribution.

Field note

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