Threaded Offset Cup Impactor — Class II medical device recall Z-2499-2019
Terminated recall by Exactech, Inc., reported 2019-09-18, distributed in AR, CA, FL, IL, IN, NY, SC, TX. The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due
| Recall number | Z-2499-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-07-24 |
| Classified | 2019-09-10 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2023-05-31 |
| Distributed | AR, CA, FL, IL, IN, NY, SC, TX |
| Quantity | 22 devices |
| UPC / GTIN / UDI-DI | 10885862520623 |
| Lot numbers | 103071001, 8182001 |
| Model numbers | 181-02-01 |
Product
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Reason for recall
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2499-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.