FDAFDA · Food and drugs·Recall number Z-1837-2014
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Published June 25, 2014 · Recall initiated: May 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
- Lot
- PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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