FDA Medical Device Recalls (openFDA)
Flower Orthopedics Corporation: T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
- Recall number
- Z-1698-2021
- Recalling firm
- Flower Orthopedics Corporation
- Product
- T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
- Status
- Terminated
- Initiated
- 2021-04-15
- Posted
- not on file
- Terminated
- 2021-11-12
- Reason
- Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
- Root cause
- Nonconforming Material/Component
- Action
- Flower Orthopedic issued Urgent Recall Information via email on 4/15/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below and quarantine immediately. Next, please complete and return the attached Acknowledgement and Receipt Form as soon as possible. Flower Orthopedics is initiating shipment of replacement product for delivery Friday April 16. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or FLOWERCS@FLOWERORTHO.COM "Acknowledgement and Product Replacement Forms (see attached)
- Quantity
- 47 units
- Distribution
- US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
- Lot, serial or model codes
- Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXX
- 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