FDA Medical Device Recalls (openFDA)
Flower Orthopedics Corporation: Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
- Recall number
- Z-1113-2017
- Recalling firm
- Flower Orthopedics Corporation
- Product
- Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
- Status
- Terminated
- Initiated
- 2016-12-22
- Posted
- not on file
- Terminated
- 2017-11-27
- Reason
- The product is being recalled due to incidence and reports of the product breaking during surgery.
- Root cause
- Device Design
- Action
- Flower Orthopedics mailed a letter to customers on December 22, 2016 making them aware of the issue. Customers were asked to return the affected product and to report if any adverse effects resulted from its use.
- Quantity
- not on file
- Distribution
- Distributed throughout the United States
- Lot, serial or model codes
- Device Listing: D267957
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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