Recall Z-0178-2021 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Bien-Air Surgery Sa
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.
| Date | Sep 11, 2020 |
| Status | Open, Classified |
| Reason | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. |
| Root cause | Process control |
| Action | On 09/14/2020, the firm send out an "URGENT: Medical Device Correction" notification informing customer of the potential for the magnet located inside the foot pedal displaces or comes off during a surgery and therefore may compromise the device's safety. The use of the incriminated devices may entail a risk of unattended start or unstoppable motor when acting on the foot pedal. The Recalling Firm is informing customers of a curative and a corrective action to prevent the magnet from coming off: -Curative Action: 1) Inspect your inventory for the product numbers/serial numbers above. 2) Quar |
| Quantity | Total US = 1120 foot pedals |
| Distribution | US Nationwide distribution including in the states of CA, MI and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA, Mar 4, 2015 |