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Terminated

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

FDA Recall Z-3102-2017 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHTO
Date Initiated2017-08-04
Date Terminated2023-06-28
Product Quantity5 units

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.

Firm Action

The firm initiated their recall by telephone and email to their sales representatives and surgeons on 08/04/2017. The letter explained the problem and advised the surgeons that the sales representative would be collecting the devices for return.

Root Cause

Employee error

Distribution Pattern

OH, VA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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