FDA-Device2021-10-13Class II
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Flower Orthopedics Corporation
Hazard
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Sold states
US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Affected count
77 kits
Manufactured in
100 Witmer Rd Ste 280, Horsham, PA, United States
Products
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0034-2022Don't want to check this manually?
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