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Recall Observatory FDA recall evidence

Device product

3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

Z-0639-2017

October 03, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 75502
Status
Terminated
Classification
Class II
Quantity
5478 units
Official record key
device-enforcement:Z-0639-2017

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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