Recall Z-2784-2020 ยท HRS Plate, Fixation, Bone
Flower Orthopedics Corporation
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.
| Date | Aug 12, 2020 (initiated Jul 8, 2020) |
| Status | Terminated |
| Reason | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium). |
| Root cause | Mixed-up of materials/components |
| 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. |
| Quantity | 25 |
| Distribution | US Nationwide distribution including in the states of AZ, FL, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET Flower Orthopedics Corporation, Mar 27, 2014 |