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
Reported: October 18, 2023 Initiated: August 29, 2023 #Z-0074-2024
Product 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
Reason for Recall
Device is breaking while in use, potential for patients to require a revision surgery.
Details
- Recalling Firm
- Flower Orthopedics Corporation
- Units Affected
- 70 units
- Distribution
- US Nationwide distribution.
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Flower Orthopedics Corporation. Units affected: 70 units.
Why was this product recalled? ▼
Device is breaking while in use, potential for patients to require a revision surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0074-2024.
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