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Recall Observatory FDA recall evidence

Device product

Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232

Z-0843-2022

January 14, 2022

Class II

Product summary

Firm
Howmedica Osteonics Corp.
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

    reason.no_named_rule · v1.0.0

    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