Device product

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

Z-0637-2017

October 03, 2016

Class II

Product summary

Firm: Synthes (USA) Products LLC
Event: Event 75502
Status: Terminated
Classification: Class II
Quantity: 1,951 units
Official record key: device-enforcement:Z-0637-2017

Official wording

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

Code information: Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875.

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.