FDA Recall
Terminated
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.
Recall: Z-2784-2020
·
Initiated July 8, 2020
Recall
- Recall Number
- Z-2784-2020
- Event Number
- 86023
- Firm
- Flower Orthopedics Corporation
- FEI Number
- 3009996260
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- July 8, 2020
- Posted
- August 12, 2020
- Terminated
- October 8, 2020
- Address
- 100 Witmer Rd, Ste 280, Horsham, PA, 19044-2647
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.
Reason
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
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.
Distribution
US Nationwide distribution including in the states of AZ, FL, and OH.
Quantity
25