R3 Acetabular System - 0 Hole Acetabular Shell, 3 Hole Acetabular Shell, 0 Hole Ha Coated Acetabular Shell, 3 Hole Ha Coated Acetabular Shell, Multi-Hole Acetabular Shell (2020-04-23)

Starting date:
April 23, 2020
Posting date:
May 15, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73085

Last updated:

Affected Products

  1. R3 Acetabular System - 0 Hole Acetabular Shell
  2. R3 Acetabular System - 3 Hole Acetabular Shell
  3. R3 Acetabular System - 0 Hole Ha Coated Acetabular Shell
  4. R3 Acetabular System - 3 Hole Ha Coated Acetabular Shell
  5. R3 Acetabular System - Multi-Hole Acetabular Shell

Reason

Smith & Nephew has initiated a voluntary recall to remove specific lots of R3 cetabular shells due to a manufacturing error. Use of the affected devices, which may not have been manufactured to their design specifications, may result in an intraoperative locking failure.

Affected products

A. R3 Acetabular System - 0 Hole Acetabular Shell

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 71331850
  • 71331852
  • 71331856
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES

B. R3 Acetabular System - 3 Hole Acetabular Shell

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 71335544
  • 71335546
  • 71335548
  • 71335550
  • 71335552
  • 71335554
  • 71335556
  • 71335558
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES

C. R3 Acetabular System - 0 Hole Ha Coated Acetabular Shell

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 71332252
  • 71332254
  • 71332256
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES

D. R3 Acetabular System - 3 Hole Ha Coated Acetabular Shell

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 71331942
  • 71331946
  • 71331948
  • 71331950
  • 71331952
  • 71331954
  • 71331956
  • 71331958
  • 71331958
  • 71331960
  • 71331962
  • 71331964
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES

E. R3 Acetabular System - Multi-Hole Acetabular Shell

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 71338663
  • 71338664
  • 71338665
  • 71338666
  • 71338667
  • 71338668
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES