Recall Z-1446-2022— Aesculap Implant Systems LLC

Name: FDA recall Z-1446-2022
Creator: U.S. Food and Drug Administration
Published: 2020-09-08

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2020-09-08, terminated 2024-04-10. It names one FDA 510(k) clearance: K062012. Product: AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.. 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..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Terminated: 2024-04-10
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K062012 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEMAesculap, Inc.·cleared 2007-02-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.