Recalls / —

—#181436

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.

FDA product code

MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K070756

Affected lot / code info

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

Why it was recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

Root cause (FDA determination)

Process control

Action the firm took

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: FieldActions@smith-nephew.com.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Worldwide

Timeline

Recall initiated

2020-04-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181436. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.