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