PlainRecalls
FDA Devices Moderate Class II Ongoing

smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.

Reported: June 17, 2020 Initiated: April 22, 2020 #Z-2336-2020

Product Description

smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.

Reason for Recall

A manufacturing error resulted in out of specification R3 Acetabular Shells

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
58 devices
Distribution
Worldwide
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.. Recalled by Smith & Nephew, Inc.. Units affected: 58 devices.
Why was this product recalled?
A manufacturing error resulted in out of specification R3 Acetabular Shells
Which agency issued this recall?
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2336-2020.