Recall Z-0617-2021— Biomet, Inc.

Name: FDA recall Z-0617-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-25

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-11-25, terminated 2024-05-08. It names one FDA 510(k) clearance: K140891. Product: 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.. Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-25
Terminated: 2024-05-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K140891 — BIOMET CANNULATED SCREW SYSTEMBiomet, Inc.·cleared 2014-06-03

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

4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.

Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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