CLASS II Device recall · Reported 13 Oct 2021 · FDA Enforcement Report

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation recalled

Flower Orthopedics is recalling Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation, distributed nationwide in the US. The recall was initiated on 3 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 2104321637 Unique Identifier: 00840118112079

Quantity recalled77 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0034-2022
FDA event ID: 88724
Recalling firm: Flower Orthopedics, Horsham, PA
Classification: Class II
Status: Terminated
Recall initiated: 3 Sep 2021
FDA classified: 6 Oct 2021
Reported: 13 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Sep 2021	Recall initiated by company
6 Oct 2021	Classified by FDA	+33 days
13 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.

Nationwide Arizona California Colorado Connecticut Florida Illinois Indiana North Carolina Nevada New York Ohio Texas West Virginia

Questions about this recall

Is Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation recalled?

Yes. Flower Orthopedics recalled Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation on 3 Sep 2021. The recall is Class II and its status is Terminated. Recall number Z-0034-2022.

Why was it recalled?

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

Which lots are affected?

Lot Number: 2104321637 Unique Identifier: 00840118112079

Where was it sold?

US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Flower Orthopedics

All 16

Reported	Class	Recall	Company	Reason	Where
18 Oct 2023Device	CLASS II	Coventus Flower Orthopedics Flex-Thread TM Cannulated recalled	Flower Orthopedics	Sterility	Nationwide
12 Jan 2022Device	CLASS II	Flex-Thread Inserter Shaft intended recalled by Flower Orthopedics	Flower Orthopedics	Other	Nationwide
20 Oct 2021Device	CLASS II	Flower Drill Bit Kit- The Drill Bit Kit recalled by Flower Orthopedics	Flower Orthopedics	Packaging Defects	10 states
20 Oct 2021Device	CLASS II	Flower Drill Bit Kit-intended to be used recalled by Flower Orthopedics	Flower Orthopedics	Packaging Defects	10 states
20 Oct 2021Device	CLASS II	Flower Lag Screw Kit-intended to be used with lag screws recalled	Flower Orthopedics	Packaging Defects	10 states

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