Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
FDA Recall Z-2338-2018 · Posted None
Recalling FirmTrilliant Surgical Ltd.
Recall StatusTerminated
Product CodeMDM
Date Initiated2018-03-27
Date Terminated2020-06-04
Product Quantity94
Reason for Recall
Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.
Firm Action
On 03/27/18, the firm sent Medical Device Recall notices to customers informing them to: 1) Check inventory stock for identified devices; 2) Locate and remove and/or discontinue use of identified devices; 3) Return all related product(s) to the firm in accordance with an included return response / acknowledgement form. Customers were instructed to contact the firm at 1-800-495-2919 to organize product returns.
Root Cause
Other
Distribution Pattern
U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.