Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF… recallZ-2784-2020 · Flower Orthopedics Corporation · initiated Jul 8, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flower Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
FDA root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-2784-2020
- Status
- Terminated
- Initiated by the company
- Jul 8, 2020
- Posted by the FDA
- Aug 12, 2020
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 25
- Product code
- HRS
- FDA submissions
- K133930
- Distribution
- US Nationwide distribution including in the states of AZ, FL, and OH.
Product description
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Code information (models, lots, serial numbers)
Lot Number 1909660033; UDI 00840118115667
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Extensile Calcaneus Plate, Large, Left CPF 103Flower Orthopedics Corporation · Plate, Fixation, Bone1 recall0 reports
Other devices under the same FDA submission
5 devices cleared under K133930 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Extensile Calcaneus Plate, Small, Left CPF 101Flower Orthopedics Corporation · Plate, Fixation, Bone1 recall0 reports
- Extensile Calcaneus Plate, Medium, Left CPF 102Flower Orthopedics Corporation · Plate, Fixation, Bone1 recall0 reports
- Extensile Calcaneus Plate, Small, Right CPF 201Flower Orthopedics Corporation · Plate, Fixation, Bone1 recall0 reports
- Extensile Calcaneus Plate, Medium, Right CPF 202Flower Orthopedics Corporation · Plate, Fixation, Bone1 recall0 reports
- Extensile Calcaneus Plate, Large, Right CPF 203Flower Orthopedics Corporation · Plate, Fixation, Bone1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86023).
- Z-2782-2020 · TerminatedCalcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot,…
- Z-2783-2020 · TerminatedCalcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot…
- Z-2785-2020 · TerminatedCalcaneus 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…
- Z-2786-2020 · TerminatedCalcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoo…
- Z-2787-2020 · TerminatedCalcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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