FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: ROSA Surgical Device 2.5.8
- Recall number
- Z-0178-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- ROSA Surgical Device 2.5.8
- Status
- Terminated
- Initiated
- 2013-02-10
- Posted
- not on file
- Terminated
- 2020-06-09
- Reason
- Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
- Root cause
- Software design
- Action
- Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.
- Quantity
- 22 units (4 US and 18 OUS)
- Distribution
- AR, OH, MI, and TX
- Lot, serial or model codes
- Serial No. RO10011, RO10014, RO13023 and RO13027
- 510(k) numbers
- ["K092239","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