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Terminated

Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

FDA Recall Z-1265-2016 · Posted 2016-03-25

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeMBH
Date Initiated2016-02-05
Date Terminated2017-03-28
Product Quantity890

Reason for Recall

The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary.

Firm Action

On 2/5/2016, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors, hospital risk managers, and implanting surgeons via courier. Distributors were instructed to locate and return the affected product, hospitals to locate and discontinue use, and implanting surgeons to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root Cause

Device Design

Distribution Pattern

UT Netherlands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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