Comprehensive Total Shoulder System/Bio-Modular Choice recall: Sterility Concern
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle…
Why was Comprehensive Total Shoulder System/Bio-Modular Choice recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers 253970 279180 417710 499280
- Product
- Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle…
- Recalling firm
- Biomet, Inc.
- Quantity
- 7428
- Distribution
- Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)