Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Recalled by Synthes (USA) Products LLC Due to The wrap is for single use for nail...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes (USA) Products LLC directly.
Affected 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.
Quantity: 1487
Why Was This 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.
Where Was This Sold?
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand.
About Synthes (USA) Products LLC
Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report