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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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 16F0005 16F0006 16F0007 16F0008 16F0009 16F0010 16F0011 16F0012 16F0013 16F0014 16F0015 16F0016 16F0017 16F0018 16F0019 16F0020 16F0021 16F0022 16F0023 16F0024 16F0025 16F0026 16F0027 16F0028 16F0029 16F0030 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020 16H0021 16H0022 16H0023 16H0024 16H0025 16H0026 16H0027 16H0028 16H0029 16H0030 16I0001 16I0002 16I0003 16I0004 16I0005 16I0006 16I0007 16I0008 16I0009 16I0010 16I0011 16I0012 16I0013 16I0014 16I0015 16I0016 16I0017 16I0018 16I0019 16I0020 16I0021 16I0022 16I0023 16I0024 16I0025 16I0026 16I0027 16I0028 16I0029 16I0030 16I0031 16I0032 16I0033 16I0034 16I0035 16I0036 16I0037 16I0038 16I0039 16I0040 16J0001 16J0002 16J0003 16J0004 16J0005 16J0006 16J0007 16J0008 16J0009 16J0010 16J0011 16J0012 16J0013 16J0014 16J0015 16J0016 16J0017 16J0018 16J0019 16J0020 16J0021 16J0022 16J0023 16J0024 16J0025 16J0026 16J0027 16J0028 16J0029 16J0030 16K0001 16K0002 16K0003 16K0004 16K0005 16K0006 16K0007 16K0008 16K0009 16K0010 16K0011 16K0012 16K0013 16K0014 16K0015 16K0016 16K0017 16K0018 16K0019 16K0020 16K0021 16K0022 16K0023 16K0024 16K0025 16K0026 16K0027 16K0028 16K0029 16K0030 17D0001 17D0002 17D0003 17D0004 17D0005 17D0006 17D0007 17D0008 17D0009 17D0010 17D0011 17D0012 17D0013 17D0014 17D0015 17D0016 17D0017 17D0018 17D0019 17D0020 17D0021 17D0022 17D0023 17D0024 17D0025 17D0026 17D0027 17D0028 17D0029 17D0030 17D0031 17D0032 17D0033 17D0034 17D0035 17D0036 17D0037 17D0038 17D0039 17D0040 17D0041 17D0042 17F0001 17F0002 17F0003 17F0004 17F0005 17F0006 17F0007 17F0008 17F0009 17F0010 17F0011 17F0012 17F0013 17F0014 17F0015 17F0016 17F0017 17F0018 17F0019 17F0020 17F0021 17F0022 17F0023 17F0024 17F0025 17F0026 17F0027 17F0028 17F0029 17F0030 17F0031 17F0032 17F0033 17F0034 17F0035 17F0036 17F0037 17F0038 17F0039 17F0040 17F0041 17F0042 17F0043 17F0044 17F0045 17F0046 17F0047 17F0048 17F0049 17F0050 17F0051 17F0052 17F0053 17F0054 17F0055 17F0056 17F0057 17F0058 17F0059 17F0060 17F0061 17F0062 17F0063 17F0064 17F0065 17F0066 17F0067 18A0001 18A0002 18A0003 18A0004 18A0005 18A0006 18A0007 18A0008 18A0009 18A0010 18A0011 18A0012 18A0013 18A0014 18A0015 18A0016 18A0017 18A0018 18A0019 18A0020 18A0021 18A0022 18A0023 18A0024 18A0025 18A0026 18A0027 18A0028 18A0029 18A0030 18D0001 18D0002 18D0003 18D0004 18D0005 18D0006 18D0007 18D0008 18D0009 18D0010 18D0011 18D0012 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bien-Air Surgery Sa
Reason for Recall:
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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.

Product Codes/Lot Numbers:

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 16F0005 16F0006 16F0007 16F0008 16F0009 16F0010 16F0011 16F0012 16F0013 16F0014 16F0015 16F0016 16F0017 16F0018 16F0019 16F0020 16F0021 16F0022 16F0023 16F0024 16F0025 16F0026 16F0027 16F0028 16F0029 16F0030 16H0001 16H0002 16H0003 16H0004 16H0005 16H0006 16H0007 16H0008 16H0009 16H0010 16H0011 16H0012 16H0013 16H0014 16H0015 16H0016 16H0017 16H0018 16H0019 16H0020 16H0021 16H0022 16H0023 16H0024 16H0025 16H0026 16H0027 16H0028 16H0029 16H0030 16I0001 16I0002 16I0003 16I0004 16I0005 16I0006 16I0007 16I0008 16I0009 16I0010 16I0011 16I0012 16I0013 16I0014 16I0015 16I0016 16I0017 16I0018 16I0019 16I0020 16I0021 16I0022 16I0023 16I0024 16I0025 16I0026 16I0027 16I0028 16I0029 16I0030 16I0031 16I0032 16I0033 16I0034 16I0035 16I0036 16I0037 16I0038 16I0039 16I0040 16J0001 16J0002 16J0003 16J0004 16J0005 16J0006 16J0007 16J0008 16J0009 16J0010 16J0011 16J0012 16J0013 16J0014 16J0015 16J0016 16J0017 16J0018 16J0019 16J0020 16J0021 16J0022 16J0023 16J0024 16J0025 16J0026 16J0027 16J0028 16J0029 16J0030 16K0001 16K0002 16K0003 16K0004 16K0005 16K0006 16K0007 16K0008 16K0009 16K0010 16K0011 16K0012 16K0013 16K0014 16K0015 16K0016 16K0017 16K0018 16K0019 16K0020 16K0021 16K0022 16K0023 16K0024 16K0025 16K0026 16K0027 16K0028 16K0029 16K0030 17D0001 17D0002 17D0003 17D0004 17D0005 17D0006 17D0007 17D0008 17D0009 17D0010 17D0011 17D0012 17D0013 17D0014 17D0015 17D0016 17D0017 17D0018 17D0019 17D0020 17D0021 17D0022 17D0023 17D0024 17D0025 17D0026 17D0027 17D0028 17D0029 17D0030 17D0031 17D0032 17D0033 17D0034 17D0035 17D0036 17D0037 17D0038 17D0039 17D0040 17D0041 17D0042 17F0001 17F0002 17F0003 17F0004 17F0005 17F0006 17F0007 17F0008 17F0009 17F0010 17F0011 17F0012 17F0013 17F0014 17F0015 17F0016 17F0017 17F0018 17F0019 17F0020 17F0021 17F0022 17F0023 17F0024 17F0025 17F0026 17F0027 17F0028 17F0029 17F0030 17F0031 17F0032 17F0033 17F0034 17F0035 17F0036 17F0037 17F0038 17F0039 17F0040 17F0041 17F0042 17F0043 17F0044 17F0045 17F0046 17F0047 17F0048 17F0049 17F0050 17F0051 17F0052 17F0053 17F0054 17F0055 17F0056 17F0057 17F0058 17F0059 17F0060 17F0061 17F0062 17F0063 17F0064 17F0065 17F0066 17F0067 18A0001 18A0002 18A0003 18A0004 18A0005 18A0006 18A0007 18A0008 18A0009 18A0010 18A0011 18A0012 18A0013 18A0014 18A0015 18A0016 18A0017 18A0018 18A0019 18A0020 18A0021 18A0022 18A0023 18A0024 18A0025 18A0026 18A0027 18A0028 18A0029 18A0030 18D0001 18D0002 18D0003 18D0004 18D0005 18D0006 18D0007 18D0008 18D0009 18D0010 18D0011 18D0012 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0179-2021

Related Recalls

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

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