FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
- Recall number
- Z-0105-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
- Status
- Terminated
- Initiated
- 2016-05-27
- Posted
- not on file
- Terminated
- 2020-06-16
- Reason
- Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
- Root cause
- Process control
- Action
- Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site.
- Quantity
- 3 units
- Distribution
- Worldwide Distribution - US (DC) and Internationally to Australia and France.
- Lot, serial or model codes
- Serial No. BR16004, BR15002, and BR15003
- 510(k) numbers
- ["K101791"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- 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