Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3102-2017 — 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

U.S. FDA — Device Enforcement · United States · 2017-08-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3102-2017
Date of alert
2017-08-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, Lp
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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