Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0641-2017)

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 Guide Rod w/Smooth Tip 950 mm, Sterile

Product Classification:

Class II

Date Initiated: October 3, 2016

Date Posted: November 30, 2016

Recall Number: Z-0641-2017

Event ID: 75502

Reason for Recall:

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

Status: Terminated

Product Quantity: 139 units

Code Information:

Catalog ID 355.042S, Lot Numbers: H085634; H094463.

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated