Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm recall: Labeling Error
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
Why was Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm recalled?
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: 89648801 89648802 89648803 89648804 89648805 GTIN: 04546540608475 ****UPDATE 3/17/22: Lot Number: 89648802 UDI: " (01)04546540608475(17)261020(10)89648802 Removed from scope of Recall: 89648801 89648803 89648804 89648805
- Product
- Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 92 units Update: 40 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, MD, MN, NC, NJ, NY, OH, OR, PA, TN, TX and the countries of Canada, China, Japan, Spain, UK, Netherlands, Germany & Belgium. ***Updated 3/17/22: U.S., Canada, China, Japan, UK, and Netherlands.
- Recall date
- April 6, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)