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Synthes (USA) Products LLC recalls Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended t
Recalled August 26, 2015 · FDA recall Z-2425-2015 · Synthes (USA) Products
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. · FDA Class II
Units
1487
Sold at
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.
Description
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.
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.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →