Reported Feb 21, 2018 · Terminated

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Persona
Partial Knee System Product UsageThe 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

Lot codes and dates: 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)
Amount recalled: 1,275 units total

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Potential for the Persona Partial Knee Impactor Pad to fracture.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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84 in total.