Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL Recalled by Smith & Nephew, Inc. Due to A manufacturing error resulted in out of specification...

Date: April 22, 2020
Company: Smith & Nephew, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.

Affected Products

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

Quantity: 1766 devices

Why Was This Recalled?

A manufacturing error resulted in out of specification R3 Acetabular Shells

Where Was This Sold?

Worldwide

About Smith & Nephew, Inc.

Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report