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Recall Observatory FDA recall evidence

Device product

Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.

Z-2425-2015

July 01, 2015

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 71713
Status
Terminated
Classification
Class II
Quantity
1487
Official record key
device-enforcement:Z-2425-2015

Official wording

Reason: The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.

Code information: all lots of part numbers: 900.50, 900.51

Distribution pattern: Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.