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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77930

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

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Event summary

Timeline bucket
August 04, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Encore Medical, Lp

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

MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

Z-3102-2017
Recall number
Z-3102-2017
Initiated
August 04, 2017
Classification
Class II
Status
Terminated
Recalling firm
Encore Medical, Lp
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.

Code information

Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000

Distribution pattern

OH, VA