Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 28, 2020
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.
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bien-Air Surgery Sa recalled Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: T… - a moderate-severity action.
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: T… was recalled by Bien-Air Surgery Sa in October 28, 2020. Reason: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.. Check the official notice for the remedy. Verify recall #Z-0179-2021 with the FDA Devices before acting.
The recall
Bien-Air Surgery Sa issued this moderate-severity FDA Devices recall-The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor..
- Moderate
- severity level
- Class II
- classification
- October 28, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0179-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0179-2021) was formally reported on October 28, 2020, with the manufacturer initiating the action on September 11, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Bien-Air Surgery Sa is listed as the recalling firm, operating out of Le Noirmont, N/A. Federal records list the affected scope as Total US = 1120 foot pedals.
The documented reason for this recall is: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of CA, MI and MN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Total US = 1120 foot pedals
Related Recalls
6
0 from same agency
Product description
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 for recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0179-2021 |
| Date reported | October 28, 2020 |
| Date initiated | September 11, 2020 |
| Recalling firm | Bien-Air Surgery Sa |
| Firm location | Le Noirmont, N/A |
| Affected scope | Total US = 1120 foot pedals |
| Distribution | US Nationwide distribution including in the states of CA, MI and MN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0179-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bien-Air Surgery Sa. Units affected: Total US = 1120 foot pedals.
Why was this product recalled? ▼
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0179-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of CA, MI and MN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0179-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 28, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.