Stradis Healthcare recalls Total Knee Pack surgical kits with potential sterility breaches due to outer bag perforations. Affected units include specific lot numbers and SKUs sold in 2015-2023.
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling Total Knee Pack surgical kits because the outer bag might tear or puncture, risking contamination of the sterile instruments. This could lead to infections during surgery if the kit is used without proper sterility.
The outer bag's potential perforation or tear could compromise the sterility of the surgical kit. If the bag is damaged, the instruments inside might become contaminated, increasing infection risk during surgery.
Surgical teams and hospitals that purchased the recalled Total Knee Pack surgical kits with specific lot numbers and SKUs. The risk is primarily for procedures where the kit is used without the outer bag being intact.
Check the product label for SKU/Part Number 570-2676 and UDI H65257026760. Affected lots include 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, and 22005482064.
Look for SKU/Part Number 570-2676 and UDI H65257026760 on the kit's label.
The outer bag may be perforated or torn, which could breach the sterility of the surgical kit.
Check the product label for the specific lot numbers and SKU listed in the recall notice. If it matches, contact Stradis Healthcare for further instructions.
Yes, if the outer bag is damaged, the instruments could become contaminated, increasing infection risk during surgery.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0864-2022 from Stradis Healthcare. 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.
