Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use
The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device that breaks during use, creating a documented risk of harm. Although no injuries have been reported, the device failure during use presents a significant risk requiring surgical intervention.
Plain-English summary
The FDA is recalling the Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer (Catalogue Number 8528-1-S) manufactured by Flower Orthopedics Corporation. This surgical instrument is used to ream and open the intramedullary canal to the appropriate depth for nail insertion during orthopedic procedures. The device is provided sterile and for single use. This recall affects 70 units distributed nationwide.
The device has been found to break while in use. When this occurs, patients may require revision surgery to address the complication caused by device failure.
The recalled product
- Product
- 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
- Manufacturer
- Flower Orthopedics Corporation
- Affected units
- 70
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI:00840118117432 Lot Number: 2304323076
Distribution
Distributed nationwide across the United States.
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