Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0639-2017)

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 w/straight Ball Tip, Sterile

Product Classification:

Class II

Date Initiated: October 3, 2016

Date Posted: November 30, 2016

Recall Number: Z-0639-2017

Event ID: 75502

Reason for Recall:

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

Status: Terminated

Product Quantity: 5478 units

Code Information:

Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085.

Distribution Pattern:

Distributed Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated