Calcaneus Plate recall
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and…
Why was Calcaneus Plate recalled?
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 1909660033; UDI 00840118115667
- Product
- Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and…
- Recalling firm
- Flower Orthopedics Corporation
- Quantity
- 25
- Distribution
- US Nationwide distribution including in the states of AZ, FL, and OH.
- Recall date
- August 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)