FDA Device recall Z-0842-2022
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
- FDA Device
- Class II
- ongoing
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 by Howmedica Osteonics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0842-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-14 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
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
Identifiers
| code_info | Lot Numbers: 89648801 89648802 89648803 89648804 89648805 GTIN: 04546540608475 ****UPDATE 3/17/22: Lot Number: 89648…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0842-2022%22
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