CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report

Calcaneus Plate, Extensile, Small, Right recalled by Flower Orthopedics

Flower Orthopedics is recalling Calcaneus Plate, Extensile, Small, Right, distributed nationwide in the US. The recall was initiated on 8 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 1909660034; UDI 00840118115674

Quantity recalled25

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-2785-2020
FDA event ID: 86023
Recalling firm: Flower Orthopedics, Horsham, PA
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2020
FDA classified: 12 Aug 2020
Reported: 19 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jul 2020	Recall initiated by company
12 Aug 2020	Classified by FDA	+35 days
19 Aug 2020	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

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Product as listed by the FDA

Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Where it was distributed

US Nationwide distribution including in the states of AZ, FL, and OH.

Nationwide Arizona Florida Ohio

Questions about this recall

Why was it recalled?

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Which lots are affected?

Lot Number 1909660034; UDI 00840118115674

Where was it sold?

US Nationwide distribution including in the states of AZ, FL, and OH.

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

Other products in this recall event

5 other products · FDA event 86023

This product is part of a recall event; the main page for the event is Calcaneus Plate, Extensile, Medium, Left recalled by Flower Orthopedics.

Reported	Class	Recall	Company	Reason	Where
19 Aug 2020	CLASS II	Calcaneus Plate, Extensile, Medium, Left recalled by Flower Orthopedics	Flower Orthopedics	Other	Nationwide
19 Aug 2020	CLASS II	Calcaneus Plate, Extensile, Large, Right recalled by Flower Orthopedics	Flower Orthopedics	Other	Nationwide
19 Aug 2020	CLASS II	Calcaneus Plate, Extensile, Small, Left recalled by Flower Orthopedics	Flower Orthopedics	Other	Nationwide
19 Aug 2020	CLASS II	Calcaneus Plate, Extensile, Medium, Right recalled by Flower Orthopedics	Flower Orthopedics	Other	Nationwide
19 Aug 2020	CLASS II	Calcaneus Plate, Extensile, Large, Left recalled by Flower Orthopedics	Flower Orthopedics	Other	Nationwide

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	Device Malfunction	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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide