Z-2785-2020Class II

Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 -

Name: Z-2785-2020 Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 -
Creator: Flower Orthopedics Corporation
Published: 2020-07-08
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2020-07-08 / Terminated / root cause: supplier

FDA source

Flower Orthopedics Corporation began a recall of Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of... on 2020-07-08. FDA classified it as Class II and gives the reason as "The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2785-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-08
Posted: 2020-08-12
Terminated: 2020-10-08
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Product: 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.
Product code: HRS Plate, Fixation, Bone
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).
Root cause tag: supplier
FDA root cause: Mixed-up of materials/components
Action: The Regional Business Director notified the customer by telephone and informed them that there was an issue with the newly released calcaneus plates. The 6 units were requested to be returned to Flower Orthopedics.
Quantity in commerce: 25
Distribution: US Nationwide distribution including in the states of AZ, FL, and OH.
Product codes and lots: Lot Number 1909660034; UDI 00840118115674

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2785-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2782-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2783-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2784-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2785-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2786-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2787-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12

Product code HRS

K133930Class IIFlower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation / cleared 2014-03-27

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)