PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 13, 2021 Initiated: September 3, 2021 #Z-0034-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
77 kits
Distribution
US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Location
Horsham, PA

Frequently Asked Questions

What product was recalled?
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201. Recalled by Flower Orthopedics Corporation. Units affected: 77 kits.
Why was this product recalled?
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Which agency issued this recall?
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0034-2022.