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 ZERO HOLE HA COATED 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 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.

Quantity: 1450 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