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Terminated

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

FDA Recall Z-0493-2014 · Posted 2013-12-13

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated0013-11-26
Date Terminated2014-09-29
Product Quantity532 in USA all under Biomet USA control

Reason for Recall

Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.

Firm Action

Beginning November 25 Urgent recall electronic notices were sent by Biomet UK to all distributors with hospitals outside the USA notified by ground mail November 27,2013. The notification identified the product and reason for the recall, asking for immediate location and discontinued use of the product and return to Biomet UK, Ltd. Questions can be addressed to Biomet USA at 01 574-372-1570 M-F 8 am to 5 pm.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.

Official Source

View FDA Recall →

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

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