FDA Device recall Z-2425-2015
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails by Synthes Usa Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2425-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-01 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | PR |
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.
Identifiers
| code_info | all lots of part numbers: 900.50, 900.51 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2425-2015%22
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