FDAFDA · Food and drugs·Recall number Z-0620-2021
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
Published December 23, 2020 · Recall initiated: November 25, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
- Lot
- Lot numbers 253970 279180 417710 499280
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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