FDA-Device2015-08-26Class II
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.
Synthes (USA) Products LLC
Hazard
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.
Sold states
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.
Affected count
1487
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2015Don't want to check this manually?
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