Recall Z-2334-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2334-2020
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 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 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 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 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.