—#95806

Product

Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 1723336, 1768306, 2049011, ZB090424.

Why it was recalled

The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. There was no injury to the patient.

Root cause (FDA determination)

Other

Action the firm took

The firm, BIOMET, sent a "FIELD SAFETY NOTICES" dated September 10, 2010, addressed to the head of orthopaedic departments, trauma departments, operating departments, sterile service departments, procurement, supplies and risk management. The notice described the product, problem and action to be taken by the customers. The letters instructed the customers to locate and immediately quarantine the recalled device; to complete and return the attached "FAX BACK RESPONSE FORM" via fax to +44 (0) 1656 645454, and the recalled device for credit via mail to Biomet UK Ltd, Waterton Industrial Estate, Bridgend, CF31 3XA. The customers were also instructed to inform all in their organization who are using or ordering the products and send a copy to the organization to which potentially affected products may have been transferred. If you have any questions regarding this communication, please contact the Quality Manager at +44 (0) 1656 655221 or email: david.broderick@biomet.com.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark

Timeline

Recall initiated: 2010-09-10
Posted by FDA: 2010-12-28
Terminated: 2011-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95806. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.