CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

T25 Cannulated Screwdrivers (CSD 025) recalled by Flower Orthopedics

Flower Orthopedics is recalling T25 Cannulated Screwdrivers (CSD 025), distributed nationwide in the US. The recall was initiated on 15 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853

Quantity recalled47 units

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-1698-2021
FDA event ID: 87906
Recalling firm: Flower Orthopedics, Horsham, PA
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2021
FDA classified: 1 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

15 Apr 2021	Recall initiated by company
1 Jun 2021	Classified by FDA	+47 days
9 Jun 2021	Published in enforcement report	+8 days

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

Reason for recall

Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300

Where it was distributed

US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.

Nationwide Arizona Colorado Florida Georgia Illinois Indiana North Carolina Pennsylvania Virginia

Questions about this recall

Why was it recalled?

Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages

Which lots are affected?

Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853

Where was it sold?

US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.

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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