Exactech Threaded Offset Cup Impactor: Gritty Mechanism Risk
Exactech recalls Threaded Offset Cup Impactor used in hip replacements due to gritty mechanism causing difficulty turning. Affected units have specific catalog and lot numbers.
Use caution until it’s fixed
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Contact the company
What happened, in plain English
Exactech recalls Threaded Offset Cup Impactor surgical tools used in hip replacements because the threaded mechanism may become gritty and hard to turn. This could lead to improper implantation during surgery. Read more at govinfonow.com/recall/67356-exactech-threaded-offset-cup-impactor-gritty-mechanism-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/67356-exactech-threaded-offset-cup-impactor-gritty-mechanism-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2499-2019
Cite this page
“Exactech Threaded Offset Cup Impactor: Gritty Mechanism Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67356-exactech-threaded-offset-cup-impactor-gritty-mechanism-risk. Based on FDA recall #Z-2499-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2499-2019%22&limit=1).
Why it’s dangerous
The threaded mechanism may trap blast media, making it gritty and difficult to turn during surgery. This could cause improper implantation of the hip replacement components.
Who’s affected
Surgeons using the Threaded Offset Cup Impactor for hip replacements are affected. The risk is highest for those using the specific catalog numbers and lot ranges mentioned in the recall.
How to tell if you have this one
Check for Catalog Number 181-02-01 and Lot Numbers 103071001 or 8182001 on the product. These tools are used by surgeons during hip replacement procedures.
- Brand
Exactech- Category
Medical device
What to do — step by step
Check Product Details
Identify the catalog number (181-02-01) and lot numbers (103071001 or 8182001) on the Threaded Offset Cup Impactor.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “US distribution to AR, CA, FL, IL, IN, NY, SC, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Florida, Illinois, Indiana, New York, South Carolina, Texas.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2499-2019 (July 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2499-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.