Recall Z-1114-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1114-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-12-16, terminated 2017-07-21. It names one FDA 510(k) clearance: K083827. Product: Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies. Reason: labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Terminated: 2017-07-21
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K083827 — ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIESBiomet Manufacturing Corp·cleared 2009-02-13

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

Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

Reason for recall

labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.

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