Recall Z-0596-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-28, terminated 2018-08-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for the Persona Partial Knee Impactor Pad to fracture..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-28
- Terminated
- 2018-08-23
- Firm location
- Warsaw, IN, United States
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.
Reason for recall
Potential for the Persona Partial Knee Impactor Pad to fracture.
Data sourced from openFDA. This site is unofficial and independent of the FDA.