Z-1446-2022Class II

AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal...

Name: Z-1446-2022 AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal...
Creator: Aesculap Implant Systems LLC
Published: 2020-09-08
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2020-09-08 / Terminated / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery on 2020-09-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1446-2022
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Posted: 2022-07-21
Terminated: 2024-04-10
Recalling firm: Aesculap Inc
Product: AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Removal Notification issued September 08, 2020 sent via USPS certified mail. The notice identifies the affected part numbers S4C CROSS CONNECTOR SW112T, SW113T, SW114T, SW115T, SW116T and SW117T and asks distributors and customers to identify existing inventory, quarantine, and return affected inventory. If further distributed, identify and notify customers. The notice includes an acknowledgement form to be completed and returned to Aesculap Inc. via email at [email protected]. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigilance (610) 984-9072.
Quantity in commerce: 23
Distribution: United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Product codes and lots: UDI-DI: 04038653362325

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1446-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1443-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1444-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1445-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1446-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1447-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1448-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code NKB

K062012Class IIS4 Cervical Occipital Plate Spinal SystemAesculap, Inc. / cleared 2007-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)