Recall Z-0297-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0297-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-05

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-06-05, terminated 2018-03-06. It names one FDA 510(k) clearance: K003294. Product: Lateral Troch Plate Full Crimp - 254mm, model # 350838. Reason: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Terminated: 2018-03-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K003294 — BIOMET LATERAL TROCH PLATEBiomet, Inc.·cleared 2000-11-03

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

Lateral Troch Plate Full Crimp - 254mm, model # 350838

Reason for recall

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

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