Howmedica Osteonics Corp. Recall 89592
Description: Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Howmedica Osteonics Corp. Recall 89592 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0843-2022 |
| Event ID | 89592 |
| Event Description | Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 |
| Product Type | Devices |
| 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. |
| Quantity | 39 units Updated: 40 units |
| Recall 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 |
| Device Classification | 20220406 |
| Device Code Info | Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202 |
| Center Classification Date | 20220331 |
| Recall Initiation Date | 20220114 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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