Recall Z-0627-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0627-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-25

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-25, terminated 2018-08-09. It names one FDA 510(k) clearance: K833921. Product: AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.. Reason: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-25
Terminated: 2018-08-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K833921 — AGC TOTAL KNEE PROSTHESISBiomet, Inc.·cleared 1984-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

Reason for recall

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Data sourced from openFDA. This site is unofficial and independent of the FDA.