Smith & Nephew, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2336-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 22, 2020

Date Posted: June 17, 2020

Recall Number: Z-2336-2020

Event ID: 85637

Reason for Recall:

A manufacturing error resulted in out of specification R3 Acetabular Shells

Status: Ongoing

Product Quantity: 58 devices

Code Information:

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

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated