Calcaneus Plate — Class II medical device recall Z-2787-2020
Terminated recall by Flower Orthopedics Corporation, reported 2020-08-19, distributed nationwide. The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the
| Recall number | Z-2787-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flower Orthopedics Corporation, Horsham, PA, United States |
| Recall initiated | 2020-07-08 |
| Classified | 2020-08-12 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2020-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 25 |
| UPC / GTIN / UDI-DI | 00840118115698 |
| Lot numbers | 1909660037 |
| Model numbers | 203 |
Product
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2787-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.