The Recall Desk
HighFDA (Devices)·Z-0626-2018·Announced 2018-02-21

Zimmer Biomet Recalls G7 Dual Mobility Hip Liners Due to Labeling Error

Zimmer Biomet is recalling 8 units of G7 Dual Mobility Liners because they are labeled as 44mm but may physically be 42mm liners.

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 high-risk medical device where a labeling error could result in the implantation of an incorrect size, posing a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 8 units of G7 Dual Mobility Liners, Item #110024464, Lot# 478340. These medical devices are intended for use in hip arthroplasty cases to replace damaged joints and restore function.

The recall was initiated because the affected products are labeled and etched as F-44 mm liners, but the physical products could potentially be E-42 mm liners. This discrepancy in size and labeling could lead to the use of an incorrect implant during surgery.

The products were distributed nationwide in the United States. Healthcare providers and patients should verify the physical dimensions of the liners against the labeling before use. If a discrepancy is found, the device should not be used and the manufacturer should be contacted.

The recalled product

Product
G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function
Affected units
8

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 (1)

  • Item #110024464 Lot# 478340

Distribution

Distributed nationwide across the United States.