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Terminated

2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

FDA Recall Z-0637-2017 · Posted 2016-11-19

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHTO
Date Initiated2016-10-03
Date Terminated2017-07-06
Product Quantity1,951 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.

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