FDA Device recall Z-0179-2021
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the ligh…
- FDA Device
- Class II
- ongoing
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the ligh… by Bien Air Surgery, citing the magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0179-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-11 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bien Air Surgery |
| Distribution | US |
Product
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.
Reason
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Identifiers
| code_info | Model 1600983 / Catalog number 1600983-001 Serial Numbers: 16D0002 16D0003 16D0004 16D0005 16D0006 16D0007 16D0…Model 1600983 / Catalog number 1600983-001 Serial Numbers: 16D0002 16D0003 16D0004 16D0005 16D0006 16D0007 16D0008 16D0009 16D0010 16D0011 16D0012 16D0013 16D0014 16D0015 16D0016 16D0017 16D0018 16D0019 16D0020 16D0021 16D0022 16D0023 16D0024 16D0025 16D0026 16D0027 16D0028 16D0029 16D0030 16D0031 16D0032 16D0033 16D0034 16D0035 16D0036 16D0037 16D0038 16D0039 16D0040 16D0041 16D0042 16D0043 16D0044 16D0045 16D0046 16D0047 16D0048 16D0049 16D0050 16D0051 16E0001 16E0002 16E0003 16E0004 16E0005 16E0006 16E0007 16E0008 16E0009 16E0010 16E0011 16E0012 16E0013 16E0014 16E0015 16E0016 16E0017 16E0018 16E0019 16E0020 16E0021 16E0022 16E0023 16E0024 16E0025 16E0026 16E0027 16E0028 16E0029 16E0030 16E0031 16E0032 16E0033 16E0034 16E0035 16E0036 16E0037 16E0038 16E0039 16E0040 16E0041 16E0042 16E0043 16E0044 16E0045 16E0046 16E0047 16E0048 16E0049 16E0050 16F0001 16F0002 16F0003 16F0004 16F |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0179-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.