FDA-Device2020-12-23Class II
6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
Biomet, Inc.
Hazard
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.
Sold states
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Affected count
7428
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0618-2021Don't want to check this manually?
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