FDAJuly 1, 2015device

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 sterili...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

synthes usa productssynthessynthes usa

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 sterili... — Recall Details · AllClear