Z-0618-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 25, 2020
- Termination Date
- May 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7428
Product Description
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.
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.
Distribution Pattern
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Code Information
Lots 167600 288790 286450 368030 180660 285790 285800 179940 179960 179980 180020 288880 288890 288750 179750