—#161434

Product

The 2nd Assist Knee Positioner

FDA product code: JEB — Table, Surgical With Orthopedic Accessories, Manual
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Item# 740026

Why it was recalled

Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.

Root cause (FDA determination)

Package design/selection

Action the firm took

On September 12, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to distributors and customers titled "The Second Assistant Disposable Knee Positioner". The notice requests customers to review their inventory and to quarantine any remaining product, which will be returned to the firm. Also, to notify any additional accounts which may have received product from you. Questions or concerns can be directed to Customer Service at 574-371-3071

Recalling firm

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

Distribution

Distribution pattern: Nationally

Timeline

Recall initiated: 2017-09-07
Terminated: 2018-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.