| Date Initiated by Firm | December 21, 2017 |
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| Create Date | April 11, 2018 |
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| Recall Status1 |
Terminated 3 on June 07, 2019 |
| Recall Number | Z-1351-2018 |
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| Recall Event ID |
79533 |
| 510(K)Number | K060287 |
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| Product Classification |
Controller, foot, handpiece and cord - Product Code EBW
|
| Product | Foot Controls
Model: S-N1 and S-N2
Product Usage:
Variable foot control for use with drive units operating mechanical instruments. |
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| Code Information |
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 |
| FEI Number |
3003755849
|
Recalling Firm/
Manufacturer |
W & H DentalWerk Burmoos GMBH - Site 1
Ignaz-Glaser-Strasse 53
Burmoos Austria
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Process change control |
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| Action | On December 22, 2017 a field safety notice was issued to customers notifying them of the potential problem with the foot controls.
On February 15, 2018 a replacement foot control was sent to customers with instructions to unplug the original foot control, cut the cable once disconnected to an electrical source and properly dispose of. The replacement foot control is to be used instead. Questions or concerns can be directed to footcontrol@wh.com |
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| Distribution | US Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = EBW
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