Z-0493-2014Class II

G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

Name: Z-0493-2014 G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Creator: Biomet, Inc.
License: https://open.fda.gov/license/

Zimmer GmbH / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0493-2014
Classification: Class II
Status: Terminated
Posted: 2013-12-13
Terminated: 2014-09-29
Recalling firm: Zimmer GmbH
Product: G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 532 in USA all under Biomet USA control
Distribution: Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.
Product codes and lots: Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0493-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0493-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)