Reported Jan 1, 2014 · Terminated

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • G7 Acetabular Screw 6.5mmx35mm
  • Part Number010001000
Lot codes and dates
  • Lot Numbers
    • 3070517
    • 3070528
    • 3077748
    • 3077750
    • 3077751
    • 3085183
    • 3105038
    • 3123395
    • 3123398
    • 3123399
    • 3123400
    • 3146439
    • 3165497
    • 3165498
    • 3165499
    • 3165500
    • 3181736
Amount recalled
532 in USA all under Biomet USA control

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 29, 2014 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.