Aesculap recalls S4 Cervical Cross Connectors (SWT113T) used in spinal fusion due to potential movement or microparticle abrasion. Affected patients should contact manufacturer for details.
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 fusion connectors that may move or cause microparticle abrasion during surgery. This could lead to complications if the connectors shift or cause tissue damage.
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.
Patients who received the recalled spinal fusion connectors during surgery are affected. Surgeons and medical staff using these connectors for spinal fusion procedures are at higher risk.
Check for the product code SWT113T on the connector. The connectors are used in spinal fusion surgery and were sold with the UDI-DI: 04038653362301.
Reach out to Aesculap Implant Systems LLC for specific instructions on whether the connector needs repair or replacement.
The cross connectors may not hold securely enough during spinal fusion surgery, causing movement on the rods and potential microparticle abrasion.
Contact Aesculap Implant Systems LLC directly for guidance on whether the connector needs repair or replacement.
The recall states potential movement or microparticle abrasion, which could lead to tissue damage, but the remedy does not specify immediate stop-use.
We’ve drafted a message you can send Aescul: Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-1444-2022 — Aescul: Aesculap Implant Systems LLC Aescul: Aesculap Implant Systems LLC Hello, I own a Aescul: Aesculap Implant Systems LLC that is covered by recall Z-1444-2022 from Aescul: Aesculap Implant Systems LLC. 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.
