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.
Reported: August 19, 2020 Initiated: July 8, 2020 #Z-2785-2020
Product Description
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.
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).
Details
- Recalling Firm
- Flower Orthopedics Corporation
- Units Affected
- 25
- Distribution
- US Nationwide distribution including in the states of AZ, FL, and OH.
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Flower Orthopedics Corporation. Units affected: 25.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2020. Severity: Moderate. Recall number: Z-2785-2020.
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