Z-0617-2021 Class II Terminated
FDA device recall Z-0617-2021 was initiated by Biomet, Inc. on November 25, 2020 and is designated Class II. 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. The recall status is terminated (terminated May 8, 2024). Affected quantity: N/A.
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
- N/A
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.
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 180720 334220 285750 285760