Z-1410-2022Class II

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

Name: Z-1410-2022 MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Creator: Aesculap Implant Systems LLC
Published: 2021-10-25
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2021-10-25 / Terminated / root cause: design

FDA source

Aesculap Implant Systems LLC began a recall of MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 on 2021-10-25. FDA classified it as Class II and gives the reason as "Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant". 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-1410-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-25
Posted: 2022-07-19
Terminated: 2024-06-12
Recalling firm: Aesculap Inc
Product: MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Product code: HXX Screwdriver
Reason for recall: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Root cause tag: design
FDA root cause: Component design/selection
Action: An Urgent Medical Device Removal Notification was issued October 25, 2021 sent via email and USPS certified mail. The notice identified the product MODULIFT VBR SZ.M 4MM SET SCREWDRIVER, part of Modulift VBR Medium Instrument Set, ST-0441 and requested customers identify and quarantine affected inventory, submit the acknowledgement form and contact AIS Customer Service to arrange for return of product at (866) 229-3002 and [email protected]. Distributors are to notify customers if product was further distributed.
Quantity in commerce: 9 pieces
Distribution: US: CA, FL, GA, IL, OH & MI
Product codes and lots: UDI-DI: 04046964067648

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1410-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1410-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)