OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
Orthosensor, Inc. is recalling 56 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Left because some were reported to have fluid 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 functional defect (fluid presence) in a medical device post-surgery, which poses a risk of harm, but the source text does not report specific injuries, hospitalizations, or deaths, nor does it explicitly state that no injuries have occurred.
Plain-English summary
Orthosensor, Inc. is recalling 56 units of OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L. The recall involves lot numbers 20579, 20601, and 20602, with UDI 00816818021416.
The recall was initiated because some sensors were reported to have fluid inside the posterior lateral corner post-surgery. The FDA has classified this as a Class II recall.
Distribution was made 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 should contact Orthosensor, Inc. for instructions on how to return the affected devices.
The recalled product
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
- Manufacturer
- Orthosensor, Inc.
- Affected units
- 56
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 (4)
- Lot numbers 20579
- 20601
- and 20602
- UDI 00816818021416.
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 →- 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
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- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
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- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
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