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Recall Observatory FDA recall evidence

Device 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 and mobility to the damaged joint.

Z-0626-2018

August 25, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79104
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0626-2018

Official wording

Reason: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.

Code information: Item #110024464 Lot# 478340

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.