Stryker recalls specific AXS Infinity LS Long Sheath models due to outer diameter specification being exceeded. Affected units include GEN-10800-70, GEN-10800-80, and GEN-10800-90 models. No remedy is stated in the recall notice.
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Stryker is recalling certain AXS Infinity LS Long Sheath models because the outer diameter specification was exceeded. This could lead to improper function during medical procedures. Affected units are identified by specific model numbers and lot numbers.
The outer diameter specification being exceeded means the sheath may not fit properly during medical procedures. This could cause complications such as tissue damage or improper device function. The hazard is specific to the medical context where precise sizing is critical.
Medical professionals using the AXS Infinity LS Long Sheath system are likely affected. Patients undergoing procedures with these sheaths may be at risk if the device malfunctions.
Check for model numbers GEN-10800-70, GEN-10800-80, or GEN-10800-90 on the sheath packaging. The lot number 20156091 and unique identifier UDI (01)07613327298253 are also associated with affected units.
Identify the model number and lot number on the sheath packaging to confirm if it is affected.
The affected models are GEN-10800-70, GEN-10800-80, and GEN-10800-90.
The recall notice does not state any remedy.
The lot number is 20156091.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-3281-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-3281-2018 from Stryker. 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.
