FDA Device recall Z-0578-2024
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536 by Exactech, citing exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0578-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-21 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | AR, FL, GA, IL, IN, KY, MD, ME, MN, NH, NV, NY, SC, TN, TX, VA |
Product
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Reason
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Identifiers
| code_info | a) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819,…a) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819, A678820, A678822, A678826, A678827, A678832, A678845, A678847, A678855, A678859, A678863; b) 01-030-40-0640, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574 |
|---|
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-0578-2024%22
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