FDAClass IIOctober 13, 2021

Flower E-Kit recall

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Why was Flower E-Kit recalled?

Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 2104321637 Unique Identifier: 00840118112079

Product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Recalling firm
Flower Orthopedics Corporation
Quantity
77 kits
Distribution
US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Recall date
October 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls