Data Foundry

Medical device recalls 2020

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED… — Class II medical device recall Z-2334-2020

Ongoing recall by Smith & Nephew, Inc., reported 2020-06-17. A manufacturing error resulted in out of specification R3 Acetabular Shells

Recall numberZ-2334-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSmith & Nephew, Inc., Memphis, TN, United States
Recall initiated2020-04-22
Classified2020-06-09
Reported by FDA2020-06-17
Quantity4,172 devices
Reason classesspecification failure
Lot numbers18DM20332, 18EM07919, 18EM13854, 18EM13857, 18EM13857A, 18EM17276, 18EM18364, 18EM19483, 18EM19487, 18EM19487A, 18EM19523, 18EM19555, 18EM19576, 18EM19577, 18EM20515, 18EM20519, 18EM20521, 18EM23148, 18EM23155, 18FM00161, 18FM01943, 18FM02384, 18FM02384A, 18FM02425, 18FM02426, 18FM02427, 18FM02432, 18FM02432B, 18FM02434, 18FM02434A, 18FM02438, 18FM02438B, 18FM02445, 18FM02445A, 18FM02564, 18FM07528, 18FM09877, 18FM10239, 18FM11142, 18FM11145 and 421 more

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 for recall

A manufacturing error resulted in out of specification R3 Acetabular Shells

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2334-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.