Aesculap recalls S4 cervical cross connectors (SW116T) used in spinal fusion surgery due to potential movement or microparticle abrasion. Affected units may require replacement.
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Aesculap is recalling specific cervical cross connectors used in spinal fusion surgery because they might move or cause microparticle abrasion. This could lead to complications during surgery or after implantation.
The cross connectors may not hold securely enough during spinal fusion surgery, causing them to move on the rods. This movement could lead to microparticle abrasion, which might damage surrounding tissues or cause infections.
Surgical teams and patients who received the recalled S4 cervical cross connectors (SW116T) for spinal fusion procedures. Surgeons and hospitals using these implants are most at risk.
Check for the product code SW116T on the connector. The item is used in spinal fusion surgery and has a UDI-DI number 04038653362332.
Reach out to Aesculap Implant Systems LLC for guidance on replacement or repair options.
The cross connectors may not hold securely enough during spinal fusion surgery, causing movement on the rods and potentially leading to microparticle abrasion.
Contact Aesculap Implant Systems LLC for guidance on replacement or repair options.
The hazard could lead to movement of the connectors or microparticle abrasion, which might cause tissue damage or infection, but the recall does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-1447-2022 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1447-2022 from Aesculap. 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.
