Flower Orthopedics Corporation recalls Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
- Recall date
- September 3, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0034-2022
- FDA classification
- Class II
- Brand / firm
- Flower Orthopedics Corporation
- Sold / distributed
- US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Why it was recalled
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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