OrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner
Orthosensor, Inc. is recalling 68 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Right 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 involves a medical device with a reported functional defect (fluid inside the sensor) that could impact performance or safety, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthosensor, Inc. is recalling 68 units of the OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R. The recall involves lot numbers 20566, 20567, 20609, and 20611, with UDI 00816818021461.
The recall was initiated because some sensors were reported to have fluid inside the posterior lateral corner post-surgery. The affected devices were distributed in 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 recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
- Manufacturer
- Orthosensor, Inc.
- Affected units
- 68
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 (5)
- Lot numbers 20566
- 20567
- 20609
- and 20611
- UDI 00816818021461.
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
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- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17
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