The Recall Desk
HighFDA (Devices)·Z-1838-2014·Announced 2014-06-25

Biomet G7 Acetabular System Positioning Guide Post Recalled for Fracture Risk

Biomet is recalling G7 Acetabular System Positioning Guide Posts because the guide rod may fracture during surgery, potentially causing a delay in the procedure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (fracture and retention in the patient) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling the G7 Acetabular System Positioning Guide Post, an orthopedic surgical instrument used for hip prostheses. The recall involves 1,047 units distributed nationwide in the United States, as well as in Canada, the Netherlands, New Zealand, and Japan.

The recall was initiated because the guide rod may fracture during the impaction of the acetabular shell. If this occurs, the fractured piece may be retained in the inserter or the patient, which could result in a delay in surgery.

Healthcare providers and patients should contact Biomet, Inc. for further information regarding this recall and the affected product lots.

The recalled product

Product
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
1,047

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · fracture

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