2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Recall Z-0644-2017 · Posted 2016-11-19
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHTO
Date Initiated2016-10-03
Date Terminated2017-07-06
Product Quantity2,157 units
Reason for Recall
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Firm Action
DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.