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Terminated

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.

FDA Recall Z-0596-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHWA
Date Initiated2017-08-28
Date Terminated2018-08-23
Product Quantity1,275 units total

Reason for Recall

Potential for the Persona Partial Knee Impactor Pad to fracture.

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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