FDA Medical Device Recalls (openFDA)
Orthosensor, Inc.: OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
- Recall number
- Z-0085-2019
- Recalling firm
- Orthosensor, Inc.
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
- Status
- Terminated
- Initiated
- 2018-07-12
- Posted
- not on file
- Terminated
- 2019-06-27
- Reason
- Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Root cause
- Under Investigation by firm
- Action
- Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.
- Quantity
- 36 devices
- Distribution
- Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
- Lot, serial or model codes
- Lot numbers 20598 and 20607, UDI 00816818021423.
- 510(k) numbers
- ["K180459"]
- PMA numbers
- not on file
- Product code
- ONN
- Firm FEI
- 3008592715
- Firm city
- Dania
- Firm state
- FL
- 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