Recalls / —

—#161749

Product

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

FDA product code

MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K113550

Affected lot / code info

Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900

Why it was recalled

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

Root cause (FDA determination)

Error in labeling

Action the firm took

The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form via digital copy to: corporatequallity.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: rgarequest@zimmerbiomet.com-specify "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 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

US Distribution to states of: FL, WI, MD, MO, and MI.

Timeline

Recall initiated

2017-10-03

Terminated

2018-08-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.