FDA Device recall Z-0931-2015
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especial…
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especial… by Synthes Usa Products, citing the device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0931-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-06 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue.
Reason
The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.
Identifiers
| code_info | All lots of part number 05.001.175, lot numbers: 28, 40, 41, 42, 53, 105, 107, 111, 112, 113, 115. |
|---|
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-0931-2015%22
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