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Recall Observatory FDA recall evidence

Device product

Synthes Trauma Nail System. The devices are indication for bone fixation.

Z-2058-2013

November 02, 2012

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 65631
Status
Terminated
Classification
Class II
Quantity
1,011,783
Official record key
device-enforcement:Z-2058-2013

Official wording

Reason: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

Code information: Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897

Distribution pattern: Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.