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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:35 PM UTC

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