Recall Z-2425-2015— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-07-01, terminated 2016-08-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-01
- Terminated
- 2016-08-18
- Firm location
- West Chester, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.