FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: ROSA Surgical Device 2.5.8
- Recall number
- Z-0115-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- ROSA Surgical Device 2.5.8
- Status
- Terminated
- Initiated
- 2016-04-08
- Posted
- not on file
- Terminated
- 2020-07-13
- Reason
- Potential for software to change the final tool orientation for the command position without command.
- Root cause
- Software design
- Action
- Field Service Technicians visited consignee locations to perform system upgrades and have been completed.
- Quantity
- 64 units
- Distribution
- AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
- Lot, serial or model codes
- Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062
- 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