Aesculap recalls S4 Cervical Cross Connectors (42-58mm) used in spinal fusion surgery due to potential movement or microparticle abrasion. Affected units have product code SW117T.
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 spinal surgery connectors that may move or cause microparticle abrasion during spinal fusion procedures. This could lead to complications if the connectors shift or create particles that damage surrounding tissue.
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 complications.
Surgical teams using the Aesculap S4 Cervical Cross Connectors (product code SW117T) for spinal fusion procedures are most at risk. Patients who have recently undergone this surgery may also be affected.
Check for the product code SW117T on the connector. These connectors are used in spinal fusion surgery and were sold with the UDI-DI 04038653362349.
Look for the product code SW117T on the connector to confirm it is affected.
The cross connectors may not hold securely enough during spinal fusion surgery, causing movement or microparticle abrasion that could damage surrounding tissues.
Check the product code on the connector. If it is SW117T, contact Aesculap for guidance.
The recall states there is a risk of movement or microparticle abrasion, which could lead to complications, but 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-1448-2022 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1448-2022 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.