FDA Device recall Z-0941-2018
Accolade and Restoration hip product
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Accolade and Restoration hip product by Howmedica Osteonics, citing inner and outer sterile barriers not fully sealed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0941-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-21 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | AR, DE, FL, IL, IN, MI, NJ, OH, TN, TX |
Product
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Reason
Inner and outer sterile barriers not fully sealed.
Identifiers
| code_info | Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0941-2018%22
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