Biomet, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0493-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

Product Classification:

Class II

Date Initiated: November 26, 2013

Date Posted: January 1, 2014

Recall Number: Z-0493-2014

Event ID: 66967

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.

Status: Terminated

Product Quantity: 532 in USA all under Biomet USA control

Code Information:

Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated