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Terminated

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

FDA Recall Z-2086-2015 · Posted 2015-07-16

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeFZO
Date Initiated2015-06-24
Date Terminated2016-08-18
Product Quantity100

Reason for Recall

It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.

Firm Action

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Root Cause

Employee error

Distribution Pattern

US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.

Official Source

View FDA Recall →

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

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