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Terminated

VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121

FDA Recall Z-0361-2008 · Posted 2007-12-08

Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-11-13
Date Terminated2007-12-13
Product Quantity10

Reason for Recall

Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.

Firm Action

Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.

Root Cause

Employee error

Distribution Pattern

Nationwide: USA including states of ID, NY, VA & WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022204VKS KNEE SYSTEMPlus Orthopedics · 2002-10-18

Official Source

View FDA Recall →

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

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