Reported Oct 18, 2023 · Ongoing
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the…
Flower Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flower Orthopedics Corporation · 100 Witmer Rd Ste 280 · Horsham, PA · 19044-2647
Is this the product you have?
- 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 Number8528-1-S
- Lot codes and dates
- UDI00840118117432
- Lot Number2304323076
- Amount recalled
- 70 units
Where it was sold
- Nationwide
Why it was recalled
Device is breaking while in use, potential for patients to require a revision surgery.
This product could cause temporary or reversible health problems — stop using it.
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