Data Foundry

Medical device recalls 2020

smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED… — Class II medical device recall Z-2332-2020

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

Recall numberZ-2332-2020
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
Quantity1,450 devices
Reason classesspecification failure
Lot numbers18EM06114, 18EM06116, 18EM13916, 18EM13916A, 18EM13916B, 18EM13934, 18EM23220, 18EM23223, 18FM00218, 18FM00235, 18FM01038, 18FM01063, 18FM02450, 18FM02451, 18FM02458, 18FM02468, 18FM11167, 18FM11173, 18FM11177, 18FM16504, 18FM16506, 18FM17594, 18FM21552, 18GM01199, 18GM01228, 18GM04749, 18GM04752, 18GM04753, 18GM06567, 18GM07672, 18GM09577, 18GM09584, 18GM16977, 18GM16978, 18GM16981, 18GM17030, 18GM18527, 18GM18527B, 18GM18527C, 18HM00807 and 131 more

Product

smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 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-2332-2020. 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.