FDAFDA · Food and drugs·Recall number Z-1838-2014
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
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: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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