OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
Orthosensor, Inc. is recalling 37 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Right knees because fluid was reported inside the posterior lateral corner post-surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as fluid accumulation in a surgical implant) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Orthosensor, Inc. is recalling 37 units of the OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R. The recall affects devices with lot numbers 20569, 20576, 20594, and 20618, and UDI 00816818021447.
The recall was initiated because some sensors were reported to have fluid inside the posterior lateral corner post-surgery. This is classified as an FDA Class II recall, indicating a reasonable probability that the use of the product could 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 instructions on returning the devices or obtaining replacements.
The recalled product
- Product
- OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
- Manufacturer
- Orthosensor, Inc.
- Affected units
- 37
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 20569
- 20576
- 20594
- and 20618
- UDI 00816818021447.
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
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- HighOrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner
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- HighOrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence
FDA (Devices) · 2018-10-17