Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0637-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 3, 2016

Date Posted: November 30, 2016

Recall Number: Z-0637-2017

Event ID: 75502

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,951 units

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

Voluntary or Mandated:

Voluntary: Firm initiated