Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Summary
The FDA issued a Class II for Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 by Flower Orthopedics Corporation. Reason: Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced).
Details
Source
Device Recall
External ID
Z-0034-2022
Action Date
2021-10-13
Status
Terminated
Category
device
Product Description
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Lot/Code Info: Lot Number: 2104321637 Unique Identifier: 00840118112079
Quantity Affected: 77 kits
Reason for Recall
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
Distribution
US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-03
Company
Horsham, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Flower Orthopedics Corporation has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Flower Orthopedics Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flower Orthopedics Corporation have FDA actions?
Flower Orthopedics Corporation has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0034-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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