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Recall Observatory FDA recall evidence

Device product

Extraction Hook - Sterile for TI Cannulated Nails

Z-0642-2017

October 03, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 75502
Status
Terminated
Classification
Class II
Quantity
114 units
Official record key
device-enforcement:Z-0642-2017

Official wording

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

Code information: Catalog ID 355.399S, Lot Numbers: H102610

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.