—#170553

Product

Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K171054
Affected lot / code info: Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030

Why it was recalled

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Zimmer Biomet conduct this recall to distributors and hospital risk managers that have unconsumed consigned inventory or inventory within their territory. Distributors notified via email on 12/21/18. Hospital risk managers, as well as distributors with product, will be notified via courier. Distributors issued letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors to return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. Questions or concerns after reviewing notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: MN, VA Foreign: Korea, New Zealand and Japan

Timeline

Recall initiated: 2018-12-21
Terminated: 2020-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170553. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.