Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0644-2017)

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 W/Ball Tip 650 mm, Sterile

Product Classification:

Class II

Date Initiated: October 3, 2016

Date Posted: November 30, 2016

Recall Number: Z-0644-2017

Event ID: 75502

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,157 units

Code Information:

Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated