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.
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
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.
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.
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.
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.
Identify the catalog number (181-02-01) and lot numbers (103071001 or 8182001) on the Threaded Offset Cup Impactor.
The recall states the threaded mechanism may become gritty and difficult to turn, which could lead to improper implantation during surgery. It is not safe to use without checking the recall details.
The recall does not specify a remedy, so check the product details to see if it matches the catalog and lot numbers mentioned. Contact Exactech for further instructions.
Look for Catalog Number 181-02-01 and Lot Numbers 103071001 or 8182001 on the Threaded Offset Cup Impactor used in hip replacements.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2499-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2499-2019 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.