OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
Orthosensor, Inc. is recalling 84 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Left because fluid was reported inside the posterior lateral corner post-surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 presence) 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 84 units of the OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left (REF ZBH-PSNCRGH712-L). The recall was initiated because some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
The affected devices are identified by lot numbers 20549, 20565, 20606, 20610, and 20615, and UDI 00816818021454. 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 return or replacement of these devices.
The recalled product
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
- Manufacturer
- Orthosensor, Inc.
- Affected units
- 84
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 (6)
- Lot numbers 20549
- 20565
- 20606
- 20610
- 20615
- UDI 00816818021454.
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 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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