2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
FDA Recall Z-1438-2010 · Posted 2010-04-26
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Recalling FirmTrilliant Surgical LTD
Recall StatusTerminated
Product CodeHWC
Date Initiated2009-04-14
Date Terminated2010-05-03
Product Quantity32 units
Reason for Recall
Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.
Firm Action
Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.
Root Cause
Other
Distribution Pattern
WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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