Flower Orthopedics Corporation recalls Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet…
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…
Read the official notice →- Date
- 2022-01-12
- Country
- United States
- Brand
- Flower Orthopedics
- Product
- Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Flower Orthopedics recalls
- 2023-10-18
USFlower Orthopedics Corporation recalls Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to…
Device is breaking while in use, potential for patients to require a revision surgery.
- 2021-10-20
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Flower Orthopedics Corporation recalls Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as…
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
FDA · DeviceFlower Orthopedics CorporationArizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas…Official notice → - 2021-10-13
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Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
FDA · DeviceFlower Orthopedics CorporationUS Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY,…Official notice →
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- 2022-01-12
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SUN PHARMACEUTICAL INDUSTRIES INC recalls Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512,…
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RemedyRepack Inc. recalls Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG:…
Failed Impurities/Degradation Specifications
FDA · DrugRemedyRepack Inc.Product was distributed to two direct accounts in MI and PA.Official notice →