Tritanium PL Cage recall in Canada: fracture risk
In plain language
This recall involves all lots of the Tritanium PL Cage, a medical device, sold in Canada. It's being recalled because it has a higher-than-acceptable rate of intra-operative fractures. If you are a patient with this device, please consult your healthcare provider for guidance.
What to do
- Consult your healthcare provider if you have received this medical device.
- Healthcare professionals should identify and quarantine affected products.
- Follow instructions from Stryker Spine regarding affected products.
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Affected products
Tritanium PL Cage
Model: 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
Lot: All lots
Why this matters
Fracture risk
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 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
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Fracture risk
What should consumers do?
Consult your healthcare provider if you have received this medical device. Healthcare professionals should identify and quarantine affected products. Follow instructions from Stryker Spine regarding affected products.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Fracture risk
When was this product recalled?
This product was recalled on June 21, 2019.