Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixat
FDA device recall Z-2785-2020 · posted 2020-08-12 · Terminated
Recall details
- Recalling firm
- Flower Orthopedics Corporation
- 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).
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 25
- Distribution
- US Nationwide distribution including in the states of AZ, FL, and OH.
- Date initiated
- 2020-07-08
- Date posted
- 2020-08-12
- Date terminated
- 2020-10-08
- Location
- Horsham, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET (K133930) | Flower Orthopedics Corporation | 2014-03-27 |