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: 2020-05-15
Affected Products
- R3 Acetabular System - 0 Hole Acetabular Shell
- R3 Acetabular System - 3 Hole Acetabular Shell
- R3 Acetabular System - 0 Hole Ha Coated Acetabular Shell
- R3 Acetabular System - 3 Hole Ha Coated Acetabular Shell
- 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