FDA Device recall Z-1057-2014
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems by Synthes, citing the Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1057-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-07 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Reason
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Identifiers
| code_info | Part No. 03.010.523, Lot Nos. 8279162 & 8429004 |
|---|
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-1057-2014%22
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