FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2784-2020
- Recalling firm
- Flower Orthopedics Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2020-07-08
- Posted
- 2020-08-12
- Terminated
- 2020-10-08
- 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.
- Lot, serial or model codes
- Lot Number 1909660033; UDI 00840118115667
- 510(k) numbers
- ["K133930"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3009996260
- Firm city
- Horsham
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28