FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
- Recall number
- Z-0639-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
- Status
- Terminated
- Initiated
- 2017-05-01
- Posted
- not on file
- Terminated
- 2020-07-13
- Reason
- Robot arm being sent to the wrong position
- Root cause
- Software design
- Action
- Urgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.
- Quantity
- 1
- Distribution
- Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
- Lot, serial or model codes
- SP16008
- 510(k) numbers
- ["K151511"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 1825034
- 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