FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
- Recall number
- Z-1448-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
- Status
- Terminated
- Initiated
- 2020-09-08
- Posted
- not on file
- Terminated
- 2024-04-10
- Reason
- 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
- 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 qa-recalls@aesculapusa.com. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigilance (610) 984-9072.
- Quantity
- 27
- Distribution
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- Lot, serial or model codes
- UDI-DI: 04038653362349
- 510(k) numbers
- ["K062012"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28