FDA Medical Device Recalls (openFDA)
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 medical knee compartment during unicondylar knee replacement.
- Recall number
- Z-0596-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-08-28
- Posted
- not on file
- Terminated
- 2018-08-23
- Reason
- Potential for the Persona Partial Knee Impactor Pad to fracture.
- Root cause
- Under Investigation by firm
- Action
- 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 CorporateQuality.PostMarket@zimmerbiomet.com.
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28