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Recall Observatory FDA recall evidence

Device product

Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

Z-2243-2013

April 18, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 64406
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2243-2013

Official wording

Reason: Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

Code information: Part Number 450.851S, Lot Number 7065061

Distribution pattern: US distribution to MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.