Device product
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Z-1838-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 68310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1047 total
- Official record key
device-enforcement:Z-1838-2014
Official wording
Reason: 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.
Code information: PN: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877.
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
Derived failure modes
-
Unknown
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.