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Recall Observatory FDA recall evidence

Device product

G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.

Z-1837-2014

May 07, 2014

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 68310
Status
Terminated
Classification
Class II
Quantity
1047 total
Official record key
device-enforcement:Z-1837-2014

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:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.