Z-0591-2018Class II

NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The...

Name: Z-0591-2018 NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The...
Creator: Aesculap Implant Systems LLC
Published: 2017-08-10
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-08-10 / Terminated / root cause: labeling and UDI

FDA source

Aesculap Implant Systems LLC began a recall of NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System... on 2017-08-10. FDA classified it as Class II and gives the reason as "The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0591-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-10
Posted: 2018-02-12
Terminated: 2018-08-08
Recalling firm: Aesculap Inc
Product: NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
Product code: HWT Template
Reason for recall: The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and possible revision surgery.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On August 21, 2017 an Urgent Medical Device Recall notification was issued titled "NS357R Tibia Trial Plateau" asking distributors to inspect Sets #0468 and follow the inspection instructions on the customer notification letter and immediately remove the affected part and return to Aesculap Implant Systems. Questions or concerns can be directed to Customer Service at 314-551-5998
Quantity in commerce: 13 Units
Distribution: USA (nationwide)
Product codes and lots: The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0591-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-12

Product code HWT

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)