Persona Partial Knee System recallZ-0596-2018 · Zimmer Biomet, Inc. · initiated Aug 28, 2017

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the Persona Partial Knee Impactor Pad to fracture.

FDA root cause category: Under Investigation by firm

What the company is doing

Consignees were notified of the recall via letter on about 08/28/2017. Instructions for distributors, sales representatives, and distributor operations leaders include to ensure affected team members are aware of the recall, review the list of hospitals included and note any not included that should be notified, and complete and return the Acknowledgement Form. Instructions for risk managers and surgeons include to ensure affected personnel are aware of the recall, ensure that the provided updated surgical technique is used, and complete and return the Certificate of Acknowledgement. Further questions or concerns can be sent to customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Questions can also be emailed to [email protected].

Recall details

Recall number: Z-0596-2018
Status: Terminated
Initiated by the company: Aug 28, 2017
Recalling firm: Zimmer Biomet, Inc.
Quantity: 1,275 units total
Product code: HWA
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.

Product description

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.

Code information (models, lots, serial numbers)

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)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Persona® 42-5399-091-00
Biomet Orthopedics, LLC · IMPACTOR
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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