Device product
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Z-0843-2022
Product summary
- Event
- Event 89592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39 units Updated: 40 units
- Official record key
device-enforcement:Z-0843-2022
Official wording
Reason: 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
Code information: Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202
Distribution pattern: 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.
Derived failure modes
-
Unknown
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