Z-0074-2024 Class II Ongoing
FDA device recall Z-0074-2024 was initiated by Flower Orthopedics Corporation on August 29, 2023 and is designated Class II. Reason for recall: Device is breaking while in use, potential for patients to require a revision surgery. The recall status is ongoing. Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- August 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI:00840118117432 Lot Number: 2304323076