Device product

3.0 mm Reaming Rod/950 mm, Sterile

Z-0638-2017

October 03, 2016

Class II

Product summary

Firm: Synthes (USA) Products LLC
Event: Event 75502
Status: Terminated
Classification: Class II
Quantity: 887 units
Official record key: device-enforcement:Z-0638-2017

Official wording

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

Code information: Catalog ID 351.71S, Lot Numbers: H000111; H033314; H067857; H067858; H069074; H069079; H087019; H090015; H090747; H100713; H123976.

Distribution pattern: Distributed Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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