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High RiskFDAfda-Z-0111-2022OTHER

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of...

Units Affected
2
Recall Date
September 1, 2021
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0111-2022.

Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0111-2022.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Flower Orthopedics Corporation or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0111-2022.

Flower Orthopedics Corporation

FDA

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Flower Orthopedics Corporation Recall FAQ

Flower Orthopedics Corporation is the subject of a medical implants safety report: Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of.... The notice was published on September 1, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 2 units are potentially affected.