FDAClass IIFebruary 21, 2018

Persona recall

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK…

Why was Persona recalled?

Potential for the Persona Partial Knee Impactor Pad to fracture.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK…
Recalling firm
Zimmer Biomet, Inc.
Quantity
1,275 units total
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.
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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