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
Product summary
- 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
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.