Aesculap recalls S4 Cervical Cross Connectors (SW112T) used in spinal fusion due to insufficient clamping force, potentially causing 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 S4 Cervical Cross Connectors (SW112T) used in spinal fusion surgery because they may move or cause microparticle abrasion. This could lead to complications during spinal fusion procedures.
The cross connectors may not hold securely enough during spinal fusion surgery, causing movement on the rods. This can lead to microparticle abrasion, which might cause tissue damage or complications.
Patients who received this spinal fusion implant during surgery are most at risk. The product is used by surgeons and patients in spinal fusion procedures.
Check for the product code SW112T on the implant. The device is used in spinal fusion surgery and has a UDI-DI number 04038653362295.
Reach out to Aesculap Implant Systems LLC for specific instructions on the recalled product.
The recall states the cross connectors may move or cause microparticle abrasion, which could lead to complications during spinal fusion surgery.
Check for the product code SW112T on the implant. The device is used in spinal fusion surgery and has a UDI-DI number 04038653362295.
Contact Aesculap Implant Systems LLC for specific instructions on the recalled product.
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-1443-2022 — 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-1443-2022 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.