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Use caution Medical device recall · FDA · Published September 8, 2020

Aesculap S4 Cervical Cross Connectors Recall: Risk of Movement or Microparticle Abrasion

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.

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Contact the company

Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/64359-aesculap-s4-cervical-cross-connectors-recall-risk-of-movement-or.

Source Summary by GovInfoNow · govinfonow.com/recall/64359-aesculap-s4-cervical-cross-connectors-recall-risk-of-movement-or · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1444-2022

Cite this page

“Aesculap S4 Cervical Cross Connectors Recall: Risk of Movement or Microparticle Abrasion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64359-aesculap-s4-cervical-cross-connectors-recall-risk-of-movement-or. Based on FDA recall #Z-1444-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1444-2022%22&limit=1).

Aesculap Implant Systems LLC voluntarily recalled the AESCULAP S4 Cervical Cross Connector L24mm due to insufficient clamping force that may cause connector movement or microparticle abrasion, according to the FDA. The agency announced the Class II recall on September 8, 2020.

How to tell if you have it

  • AESCULAP S4 Cervical Cross Connector L24mm
  • S4C CROSS CONNECTOR FIXED 24MM
  • Product code: SWT113T
  • UDI-DI: 04038653362301

The hazard

The cross connectors in the spinal surgical system have insufficient clamping force, which may lead to movement of the connectors on the rods and/or microparticle abrasion.

Context

GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since August 10, 2017. Other recent recalls include a July 20, 2023 recall for visual field obstruction risk and a May 18, 2023 recall for incorrect product codes. Similar product recalls include an August 19, 2026 detachment risk for Olymp BiCOAG Hemostasis Probes and a March 19, 2026 high endotoxin level recall for Medline Spinal Fusion Kits.

How to tell if you have this one

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.

  • Brand
    Aescul: Aesculap Implant Systems LLC
  • Category
    Medical device
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Recall numberProduct, codes & lotsQuantity
Z-1443-2022AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.; UDI-DI: 0403865336229524
Z-1444-2022AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.; UDI-DI: 0403865336230124
Z-1445-2022AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.; UDI-DI: 0403865336231824
Z-1446-2022AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.; UDI-DI: 0403865336232523
Z-1447-2022AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.; UDI-DI: 0403865336233220
Z-1448-2022AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.; UDI-DI: 0403865336234927
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Aesculap Implant Systems LLC for specific instructions on whether the connector needs repair or replacement.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Illinois, Indiana, Michigan, Nevada, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Wyoming.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

1. Firm started the recall: Sep 8, 202012. FDA classified it Class II: Jul 21, 202223. Published in FDA’s Enforcement Report: Jul 27, 202234. FDA terminated the recall: Apr 10, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1444-2022 (September 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1444-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA