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Terminated

Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.

FDA Recall Z-2104-2011 · Posted 2011-04-28

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2011-03-03
Date Terminated2011-07-27
Product Quantity8

Reason for Recall

The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".

Firm Action

Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm. For questions regarding this recall call 574-372-3983.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915132MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEMBiomet, Inc. · 1992-02-11

Official Source

View FDA Recall →

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

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