Medical device recalls Moderate risk

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

Get recall alerts

Free email alert whenever Flower Orthopedics Corporation has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Flower Orthopedics Corporation