Reported Jan 12, 2022 · Terminated
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue…
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?
- 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 Number8435-1
- Lot codes and dates
- Lot Number11090
- UDI00840118117548
- Amount recalled
- 48 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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