Recall Z-0179-2021 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Bien-Air Surgery Sa
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.
| 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 |