PlainRecalls
FDA Devices Moderate Class II Terminated

3.0 mm Reaming Rod/950 mm, Sterile

Reported: November 30, 2016 Initiated: October 3, 2016 #Z-0638-2017

Product Description

3.0 mm Reaming Rod/950 mm, Sterile

Reason for Recall

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Details

Units Affected
887 units
Distribution
Distributed Nationwide
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
3.0 mm Reaming Rod/950 mm, Sterile. Recalled by Synthes (USA) Products LLC. Units affected: 887 units.
Why was this product recalled?
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0638-2017.