CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report
Coventus Flower Orthopedics Flex-Thread TM Cannulated recalled
Flower Orthopedics is recalling Coventus Flower Orthopedics Flex-Thread TM Cannulated Reamer-used to ream and, distributed nationwide in the US. The recall was initiated on 29 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0074-2024
- FDA event ID
- 93024
- Recalling firm
- Flower Orthopedics, Horsham, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Aug 2023
- FDA classified
- 6 Oct 2023
- Reported
- 18 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 29 Aug 2023 | Recall initiated by company | |
| 6 Oct 2023 | Classified by FDA | +38 days |
| 18 Oct 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device is breaking while in use, potential for patients to require a revision surgery.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Coventus Flower Orthopedics Flex-Thread TM Cannulated Reamer-used to ream and recalled?
Yes. Flower Orthopedics recalled Coventus Flower Orthopedics Flex-Thread TM Cannulated Reamer-used to ream and on 29 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0074-2024.
Why was it recalled?
Device is breaking while in use, potential for patients to require a revision surgery.
Which lots are affected?
UDI:00840118117432 Lot Number: 2304323076
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Flower Orthopedics
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Flex-Thread Inserter Shaft intended recalled by Flower Orthopedics | Flower Orthopedics | Other | Nationwide |
| Device | CLASS II | Flower Drill Bit Kit- The Drill Bit Kit recalled by Flower Orthopedics | Flower Orthopedics | Packaging Defects | 10 states |
| Device | CLASS II | Flower Drill Bit Kit-intended to be used recalled by Flower Orthopedics | Flower Orthopedics | Packaging Defects | 10 states |
| Device | CLASS II | Flower Lag Screw Kit-intended to be used with lag screws recalled | Flower Orthopedics | Packaging Defects | 10 states |
| Device | CLASS II | Flower Drill Bit Kit - intended to be used recalled | Flower Orthopedics | Packaging Defects | 10 states |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |