Recall Z-2335-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2335-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-22

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-04-22. It names one FDA 510(k) clearance: K070756. 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: A manufacturing error resulted in out of specification R3 Acetabular Shells.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-04-22
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K070756 — SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEMSmith & Nephew, Inc.·cleared 2007-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.