FDA Device recall Z-0581-2024
Exactech Novation Hip System, Catalog Numbers: 134-36-45
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Exactech Novation Hip System, Catalog Numbers: 134-36-45 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-0581-2024 |
| 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 Novation Hip System, Catalog Numbers: 134-36-45
Reason
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Identifiers
| code_info | GTIN 10885862024046, Serial Numbers: A763009, A763010, A763011, A763017, A763018, A763020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Exactech
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
FDA Device · Class II · 2026-03-18 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Des…
FDA Device · Class II · 2025-11-26 · Exactech - Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product De…
FDA Device · Class II · 2025-11-26 · Exactech
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2024%22
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