FDA recall Z-2331-2020

Product

smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.

Reason for recall

A manufacturing error resulted in out of specification R3 Acetabular Shells

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2020-04-22

Report date

2020-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2020