FDAClass IIJune 25, 2014

G7 Acetabular System Positioning Guide Post recall

G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.

Why was G7 Acetabular System Positioning Guide Post recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

PN: 110003500. Lots 469610, ZB130701, ZB130702, ZB130703, ZB130901, ZB131001, ZB131002, 881430, ZB131101, ZB140101, and 360877.

Product
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Recalling firm
Biomet, Inc.
Quantity
1047 total
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
Recall date
June 25, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls