FDA-Device2021-06-09Class II

Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

Signature Orthopedics Pty Limited
Hazard

Product mislabeled, with the incorrect product inside the package.

Sold states
US Nationwide distribution in the state of NC.
Affected count
3 units
Manufactured in
Lane Cove W, 7 Sirius Rd, Lane Cove West, Australia
Products
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2021

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