Health product recall

Tritanium PL Cage (2018-11-28)

Starting date:
November 28, 2018
Posting date:
June 21, 2019
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-70223

Last updated: 2019-06-21

Affected Products

Tritanium PL Cage

Reason

Stryker's complaint trending process detected that the occurrence rate of intra-operative fractures for the Tritanium PL Cages was found to be 0.0016, Which is above the threshold of 0.0002 per the risk table DHF0000038446 rev 02.

Affected products

Tritanium PL Cage

Lot or serial number

All lots.

Model or catalog number

48952070
48952080
48952090
48952100
48952110
48952120
48952130
48952140
48953070
48953080
48953090
48953100
48953110
48953120
48953130
48953140
48954076
48954086
48954096
48954106
48954116
48954126
48954136
48954146
48955076
48955086
48955096
48955106
48955116
48955126
48955136
48955146

Companies
Manufacturer
Stryker Spine
2 PEARL COURT
ALLENDALE
07401
New Jersey
UNITED STATES