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…

Recall date

July 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2425-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.