Zimmer Biomet, Inc.: Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the

Is my product affected?

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.

• UPC 42539909100
• UPC 00880304810242

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. is recalling 1,275 units of the Persona Partial Knee Impactor Pad due to a potential for the pad to fracture. The impactor pad is a surgical instrument used by surgeons to help implant partial knee replacement components. The recalled units were distributed nationwide across 16 U.S. states (Arizona, California, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, New Jersey, New Mexico, Pennsylvania, South Carolina, Texas, Washington, and Wisconsin) and internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.

The recalled product has Item Number 42539909100 and includes nine specific lot numbers ranging from 63517759 to 63705328. The source document does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for the Persona Partial Knee Impactor Pad to fracture.

Details from the source

Reason for recall: Potential for the Persona Partial Knee Impactor Pad to fracture. Distribution: US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, UK. Quantity: 1,275 units total Lot/code info: Item No. 42539909100; Lot No. (UDI No.): 63517759 ((01) 00880304810242 (10) 63517759), 63555750 ((01) 00880304810242 (10) 63555750), 63555752 ((01) 00880304810242 (10) 63555752), 63561883 ((01) 00880304810242 (10) 63561883), 63561884 ((01) 00880304810242 (10) 63561884), 63594911((01) 00880304810242 (10) 63594911), 63594914 ((01) 00880304810242 (10) 63594914), 63698564 ((01) 00880304810242 (10) 63698564), 63705328 ((01) 00880304810242 (10) 63705328)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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