REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral

FDA device recall Z-1833-2011 · posted 2011-03-28 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Biomet has initiated this action due to the scale on the stylus of the Vanguard MP Slldex AP Sizer being incorrect for this assembly resulting in the scale being out of position.

Action taken

The firm, Biomet, sent a "FIELD SAFETY NOTICE" dated February 11, 2011 to all customers (heads of Orthopaedic Departments/Operating Departments /Sterile Services Departments/Procurement /Supplies/ Risk Management). The notice described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the product; return to Biomet or their local Biomet distributor; ensure that the operating staff are made aware of this issue, and complete and return the FAX BACK RESPONSE FORM to Biomet UK Ltd or their local Biomet distributor via fax at +44 (0) 1656 645454. If you have any questions regarding this communication, please contact the Regulatory & Compliance Manager at +44 (0) 1793 645317 or email: edward.spearpoint@biometeurope.com.

Root cause

Process change control

Status

Terminated

Product code

FZX

Quantity affected

17

Distribution

Foreign only; UK, Malta, The Netherlands, Italy, Turkey, Switzerland.

Date initiated

2011-02-10

Date posted

2011-03-28

Date terminated

2011-05-16

Location

Warsaw, IN