The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1837-2014·Announced 2014-06-25

Biomet G7 Acetabular System Positioning Guide Rod Recalled for Fracture Risk

Biomet is recalling G7 Acetabular System Positioning Guide Rods because they may fracture during surgery, potentially causing retained fragments or surgical delays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II and involves a risk of harm (fracture and retained fragments) without reported illnesses or injuries, meeting the criteria for a High severity score.

Plain-English summary

Biomet, Inc. is recalling the G7 Acetabular System Positioning Guide Rod, an orthopedic surgical instrument used for hip prosthesis. The recall involves 1,047 units distributed nationwide in the United States, as well as in Canada, the Netherlands, New Zealand, and Japan. The specific product number is 110003458, and the affected lots are 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304, and ZB140201.

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 the surgery. The FDA has classified this as a Class II recall.

Healthcare facilities and consumers should stop using the affected guide rods immediately. Biomet, Inc. is the recalling firm responsible for managing the recall process.

The recalled product

Product
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
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 (9)

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

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 →

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