OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9… recallZ-0085-2019 · Orthosensor, Inc. · initiated Jul 12, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthosensor, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0085-2019
- Status
- Terminated
- Initiated by the company
- Jul 12, 2018
- Recalling firm
- Orthosensor, Inc.
- Quantity
- 36 devices
- Product code
- ONN
- FDA submissions
- K180459
- Distribution
- Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
Product description
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Code information (models, lots, serial numbers)
Lot numbers 20598 and 20607, UDI 00816818021423.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VERASENSE VERASENSE for Zimmer Biomet Persona CR C-D/3-9 RightOrthosensor Inc · Intraoperative Orthopedic Joint Assessment Aid1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80845).
- Z-0082-2019 · TerminatedOrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
- Z-0083-2019 · TerminatedOrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
- Z-0084-2019 · TerminatedOrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
- Z-0086-2019 · TerminatedOrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
- Z-0087-2019 · TerminatedOrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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