Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0638-2017)

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:

3.0 mm Reaming Rod/950 mm, Sterile

Product Classification:

Class II

Date Initiated: October 3, 2016

Date Posted: November 30, 2016

Recall Number: Z-0638-2017

Event ID: 75502

Reason for Recall:

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

Status: Terminated

Product Quantity: 887 units

Code Information:

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

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated