OrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Lateral Corner
Orthosensor, Inc. is recalling 41 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Left knees because fluid was reported inside the posterior lateral corner after 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, and the hazard involves a functional defect (fluid inside the sensor) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Orthosensor, Inc. is recalling 41 units of the OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left (REF ZBH-PSNCREF311-L). The recall involves lot numbers 20568, 20575, 20581, 20584, 20621, 20623, and 20628, with UDI 00816818021430.
The recall was initiated because some sensors were reported to have fluid inside the posterior lateral corner post-surgery. This is a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
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 and patients should contact Orthosensor, Inc. for further instructions regarding the affected devices.
The recalled product
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
- Manufacturer
- Orthosensor, Inc.
- Affected units
- 41
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 (8)
- Lot numbers 20568
- 20575
- 20581
- 20584
- 20621
- 20623
- and 20628
- UDI 00816818021430.
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
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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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