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

FDA device recall Z-0591-2018 · posted 2018-02-12 · Terminated

Recall details

Recalling firm

Aesculap Implant Systems LLC

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.

Action taken

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

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

HWT

Quantity affected

13 Units

Distribution

USA (nationwide)

Date initiated

2017-08-10

Date posted

2018-02-12

Date terminated

2018-08-08

Location

Center Valley, PA