Reported Jun 17, 2020 · Ongoing

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

Smith & Nephew, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804

Is this the product you have?

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

8 of 8 products

Products covered by this recall
Model / numberProduct as published
71338733number 48MM
7133873450MM
7133873552MM
7133873654MM
7133873756MM
7133873858MM
7133874062MM
7133874164MM
Lot codes and dates

7 of 7 products

Products covered by this recall
#Product as published
1Lot Numbers: 19DM28114 71338735
2Lot Numbers: 19DM28116 71338736
3Lot Numbers: 19EM19673, 19EM19683, 19EM19678 71338737
4Lot Numbers: 18JM12872 71338738
5Lot Numbers: 18FM02387 71338740
6Lot Numbers: 18JM02713 71338741
7Lot Numbers: 19AM22770, 19AM22770A
Amount recalled
58 devices

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Why it was recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.