Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: 11090 UDI: 00840118117548
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Flower Orthopedics Corporation
- Reason for Recall:
- Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Product Codes/Lot Numbers:
Lot Number: 11090 UDI: 00840118117548
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0448-2022
Related Recalls
Device is breaking while in use, potential for patients to require a revision surgery.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure