Aesculap recalls S4 Cervical Cross Connectors (SW114T) used in spinal fusion due to potential movement or microparticle abrasion. Affected patients should contact the 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 (SW114T) used in spinal fusion surgery because they may move on rods or cause microparticle abrasion. This could lead to complications during spinal fusion procedures.
The cross connectors may not hold securely on spinal rods, causing movement. This movement could lead to microparticle abrasion, which might cause tissue damage during spinal fusion procedures.
Patients who have undergone spinal fusion surgery using this specific connector model are most at risk. The recall applies to the S4C CROSS CONNECTOR FIXED 26MM with product code SW114T.
Check for the product code SW114T on the connector. The item is used in spinal fusion surgery and has a UDI-DI number 04038653362318.
Reach out to Aesculap Implant Systems LLC for specific guidance on the recalled product.
The recall indicates a potential risk of movement or microparticle abrasion, so it is not recommended for use without manufacturer consultation.
Contact Aesculap Implant Systems LLC directly for instructions on the recalled item.
Look for the product code SW114T on the connector, which is used in spinal fusion surgery with UDI-DI number 04038653362318.
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-1445-2022 — 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-1445-2022 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.
