Health product recall

JOURNEY Knee System - Femoral OXINIUM and COCR Nonporous Bi-Cruciate Stabilized (BCS) (2018-06-19)

Starting date:
June 19, 2018
Posting date:
July 5, 2018
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-67186

Affected products

A. JOURNEY Knee System - Femoral OXINIUM Nonporous Bi-Cruciate Stabilized (BCS)
B. JOURNEY Knee System - Femoral COCR Nonporous Bi-Cruciate Stabilized (BCS)

Reason

The analysis of available post-market surveillance data suggests that patients that have been implanted with a first generation JOURNEY BCS Knee System may have a higher risk of requiring a revision earlier than they or their surgeon had expected.

Affected products

A. JOURNEY Knee System - Femoral OXINIUM Nonporous Bi-Cruciate Stabilized (BCS)

Lot or serial number

All lots.

Model or catalog number

74021110
74021111
74021112
74021113
74021114
74021115
74021116
74021117
74021118
74021119
74021120
74021121
74021122
74021123
74021124
74021125
74021126
74021127
74021128
74021129

Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES

B. JOURNEY Knee System - Femoral COCR Nonporous Bi-Cruciate Stabilized (BCS)

Lot or serial number

All lots.

Model or catalog number

74021210
74021211
74021212
74021213
74021214
74021215
74021216
74021217
74021218
74021219
74021220
74021221
74021222
74021223
74021224
74021225
74021226
74021227
74021228
74021229

Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES