Calcaneus 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, including the calcaneus.
This recall has been terminated (originally issued August 12, 2020).
- Company
- Flower Orthopedics Corporation
- Recall Initiated
- July 8, 2020
- Posted
- August 12, 2020
- Terminated
- October 8, 2020
- Recall Number
- Z-2782-2020
- Quantity
- 25
- Firm Location
- Horsham, PA
- Official Source
- View on FDA website ↗
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).
Distribution
US Nationwide distribution including in the states of AZ, FL, and OH.
Lot / Code Info
Lot Number 1909660028; UDI 00840118115643
Root Cause
Mixed-up of materials/components
Action Taken
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.
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