OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
Orthosensor, Inc. is recalling 36 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Right knees because fluid was reported inside the posterior lateral corner post-surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential device malfunction (fluid presence) in a medical implant, which poses a risk of harm, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthosensor, Inc. is recalling 36 units of OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right (REF ZBH-PSNCRCD39-R). The recall involves lot numbers 20598 and 20607, with UDI 00816818021423.
The recall was initiated because some sensors were reported to have fluid inside the posterior lateral corner post-surgery. The devices were distributed to California, Florida, Illinois, Indiana, Michigan, New York, and North Carolina, as well as to Australia. There was no government or military distribution.
Healthcare providers and patients should contact Orthosensor, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
- Manufacturer
- Orthosensor, Inc.
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot numbers 20598 and 20607
- UDI 00816818021423.
Distribution
Part of a larger recall action
This product is one of 6 recalled by Orthosensor, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Orthosensor, Inc.
See all →- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- SevereOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Lateral Corner
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner
FDA (Devices) · 2018-10-17
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