FDA recall Z-0626-2018

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.

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-08-25

Report date

2018-02-21

Termination date

2018-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0626-2018