FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
- Recall number
- Z-0102-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
- Status
- Terminated
- Initiated
- 2014-02-14
- Posted
- not on file
- Terminated
- 2020-09-16
- Reason
- An undetected shift between the information displayed in the navigation software and the actual patient anatomy
- Root cause
- Error in labeling
- Action
- There were 4 units imported into the US and all have been corrected.
- Quantity
- 21 (4 US and 17 OUS)
- Distribution
- OH, MI and TX
- Lot, serial or model codes
- Serial #s; RO10009, RO10011, RO10014, and RO13023
- 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