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Recall Observatory FDA recall evidence

Device product

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

August 04, 2017

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 77930
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-3102-2017

Official wording

Reason: 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

Derived failure modes

  • 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.