🔍 RecallPedia

Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S

Class I - Dangerous
🏥 Medical Devices Recalled: August 29, 2023 Flower Orthopedics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI:00840118117432 Lot Number: 2304323076
  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:
Flower Orthopedics Corporation
Reason for Recall:
Device is breaking while in use, potential for patients to require a revision surgery.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S

Product Codes/Lot Numbers:

UDI:00840118117432 Lot Number: 2304323076

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0074-2024

Related Recalls

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

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Class I - Dangerous

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

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Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

Flower Orthopedics

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

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