FDA Device

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.

Hazard

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

What You Should Do

Remedy

Letters dated 7/12/2018 were either delivered by the sales representatives or issued via email to their consignees on 7/13/2018 explaining the reason for recall and requesting return of the devices, if still available, for replacement. The firm expanded the recall via letter dated 8/29/2018 for delivery by sales representatives or via sales representative email on 8/30/2018.

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Products

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Brand
Orthosensor, Inc.
UPC
Lot numbers 20568, 20575, 20581, 20584, 20621, 20623, and 20628, UDI 00816818021430.

Units Affected

41 devices

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