—#161469

Product

Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023546
Affected lot / code info: Lot Number: 473290, Exp. Date 5/19/2022

Why it was recalled

Knee implant components (tibial bearings) are labeled with the incorrect size.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Zimmer Biomet sent an Urgent Medical Device Recall letter dated September 29, 2017 to their customers. The letter identified the affected product, problems and actions to be taken. Customers were instructed to remove the affected product from inventory and provide to their Zimmer sales representative or, if the consignee is a distributor, to ship the affected product back to Zimmer. Consignees were also asked to complete a recall response form and send this back to the firm. Returns are being physically destroyed. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands

Timeline

Recall initiated: 2017-09-29
Terminated: 2019-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161469. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.