FDA Device recall Z-1351-2018
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments by W And H Dentalwerk Burmoos Site 1, citing during continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1351-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-21 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | W And H Dentalwerk Burmoos Site 1 |
| Distribution | US |
Product
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Reason
During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.
Identifiers
| code_info | REF: 05046200 05046200 05046211 05046210 06202400 06202400 30285000 30285001 Serial number "SN…REF: 05046200 05046200 05046211 05046210 06202400 06202400 30285000 30285001 Serial number "SN" from to (including) 22400 23429 E02201 E02485 E01011 E01033 E01035 E01071 24315 34040 E01358 E01658 01001 02318 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1351-2018%22
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