FDA Medical Device Recalls (openFDA)
Orthosoft, Inc. dba Zimmer CAS: Navitrack System - OS Knee Universal, Stereotaxic instrument
- Recall number
- Z-2076-2017
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Product
- Navitrack System - OS Knee Universal, Stereotaxic instrument
- Status
- Terminated
- Initiated
- 2008-10-28
- Posted
- 2017-05-12
- Terminated
- 2017-05-15
- Reason
- Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .
- Root cause
- Software design
- Action
- This is a retrospective report of a correction taken on 28 October, 2008. The software issues mentioned above were corrected in subsequent software updates. There were 153 units of the affected software distributed. There were 147 of the 153 units confirmed to have installed the updated software per the correction notice for a total percentage of 96%. Recall Notices were sent to customers on 10/28/2008.
- Quantity
- 153
- Distribution
- Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom
- Lot, serial or model codes
- Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42
- 510(k) numbers
- ["K060336"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3003714383
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
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