Exactech recalls Novation Hip System (catalog 134-36-45) due to vacuum bag loss risk. Affected units may have internal vacuum failure.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling hip implants with catalog number 134-36-45 because some units have a vacuum bag that can lose vacuum. This could lead to improper implant function if the vacuum fails during surgery.
The inner vacuum bag in the implant can lose vacuum, which may cause improper positioning of the hip implant during surgery. This could lead to the implant not functioning correctly if the vacuum fails.
Patients who received the Exactech Novation Hip System with catalog number 134-36-45 are affected. Surgeons and medical teams using these implants during procedures are most at risk.
Check for catalog number 134-36-45 on the implant packaging or documentation. Serial numbers A763009 through A763020 are also affected units.
Review the catalog number and serial numbers listed on the implant packaging or documentation to confirm if it is affected.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Check for catalog number 134-36-45 or serial numbers A763009 through A763020 on the implant packaging or documentation.
The recall record does not specify a remedy, so contact Exactech directly for guidance.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0581-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0581-2024 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.
