RegWardenFDA facility compliance records
Recall

Class II — Flower Orthopedics Corporation

Recalling firmFLOWER ORTHOPEDICS CORPORATION
Registered facilityFLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonDevice is breaking while in use, potential for patients to require a revision surgery.
ProductCoventus 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
Quantity70 units
DistributionUS Nationwide distribution.
Initiated2023-08-29
Classified2023-10-06
Recall numberZ-0074-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Flower Orthopedics Corporation (Z-0074-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93024/

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