FDA recall Z-2335-2020

Product

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 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-2335-2020