Aesculap recalls S4 cervical cross connectors used in spinal fusion surgery due to potential movement causing spinal instability. Affected models include S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T.
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 may move too much on the spinal rods, risking instability. This could lead to complications during surgery if the connectors shift.
The cross connectors may not hold securely enough on spinal rods during surgery, causing them to move. This movement could lead to instability in the spinal fusion site, potentially causing complications like misalignment or delayed healing.
Surgical teams and patients who have received the recalled S4 cervical cross connectors during spinal fusion procedures. Surgeons using these connectors in surgery are most at risk of complications.
Check for the model names: S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, or SW115T. These connectors were used in spinal fusion surgeries and have the UDI-DI code 04038653362325.
Identify if your spinal fusion surgery used the S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, or SW115T model.
The cross connectors may not hold securely enough on spinal rods during surgery, causing movement that could lead to instability in the spinal fusion site.
Check if your spinal fusion surgery used the specific model names listed in the recall. If you do, contact Aesculap for further instructions.
The recall states the connectors may move, potentially causing instability during surgery, but the remedy is not specified in the record.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-1446-2022 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1446-2022 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.
