Z-2336-2020Class II

smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following...

Name: Z-2336-2020 smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following...
Creator: Smith & Nephew, Inc.
Published: 2020-04-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-04-22 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM... on 2020-04-22. FDA classified it as Class II and gives the reason as "A manufacturing error resulted in out of specification R3 Acetabular Shells". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2336-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-22
Posted: 2020-06-09
Recalling firm: Smith & Nephew, Inc.
Product: 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.
Product code: MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Reason for recall: A manufacturing error resulted in out of specification R3 Acetabular Shells
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: [email protected].
Quantity in commerce: 58 devices
Distribution: Worldwide
Product codes and lots: 71338733, Lot Numbers: 19DM28110, 19DM28106, 19DM28106A 71338734, Lot Numbers: 19DM28114 71338735, Lot Numbers: 19DM28116 71338736, Lot Numbers: 19EM19673, 19EM19683, 19EM19678 71338737, Lot Numbers: 18JM12872 71338738, Lot Numbers: 18FM02387 71338740, Lot Numbers: 18JM02713 71338741, Lot Numbers: 19AM22770, 19AM22770A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2336-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2332-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2333-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2334-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2335-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2336-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09

Product code MBL

K070756Class IISmith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. / cleared 2007-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)