BioHorizons Canada Medical Devices recall in Canada: unlicensed devices
In plain language
This recall involves various BioHorizons Canada medical devices sold in Canada. They are being recalled because they were imported and distributed without being licensed by Health Canada. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers if provided.
- Return the product as instructed.
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Affected products
Astra OsseospeedInterface non-engaging NP 3
Model: DES-15.023
Lot: 13946
Nobel ActiveTi Base non engaging Active 3.0
Model: DES-15.068
Lot: 11994
Nobel ActiveTi Base non engaging Active WP
Model: DES-15.069
Lot: 12897 15065
ConelogTi Base non engaging 3.3
Model: DES-15.074
Lot: 13038
ConelogTi Base non engaging 3.8 / 4.3
Model: DES-15.075
Lot: 13725
ConelogTi Base non engaging 5.0
Model: DES-15.076
Lot: 13724
BioHorizons (int)Ti Base non engaging 3.5 (Bio Horizons Int)
Model: DES-15.087
Lot: 15066
BioHorizons (int)Ti Base non engaging 4.5 (Bio Horizons Int)
Model: DES-15.088
Lot: 15067
BioHorizons (int)Ti Base non engaging 5.7 (Bio Horizons Int)
Model: DES-15.089
Lot: 13722
Astra OsseospeedInterface engaging NP
Model: DES-16.023
Lot: 12593
Nobel ActiveInterface engaging 3.0
Model: DES-16.068
Lot: 15278
Nobel ActiveInterface engaging WP
Model: DES-16.069
Lot: 17187
Straumann Tissue LevelInterface engaging NNC 3.3
Model: DES-16.070
Lot: 12413
ConelogInterface engaging 3.3 Conelog
Model: DES-16.074
Lot: 12769
ConelogInterface engaging 3.8 / 4.3 Conelog
Model: DES-16.075
Lot: 15200
ConelogInterface engaging 5.0 Conelog
Model: DES-16.076
Lot: 12898
MIS C1 / V3Interface engaging C1 / V3 SP
Model: DES-16.082
Lot: 12208
BioHorizons (int)Interface engaging 3.5
Model: DES-16.087
Lot: 17194
BioHorizons (int)Interface engaging 4.5
Model: DES-16.088
Lot: 16561
BioHorizons (int)Interface engaging 5.7
Model: DES-16.089
Lot: 13722
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: 11994, 12208, 12413, 12593, 12769, 12897 15065, 12898, 13038, 13722, 13724, 13725, 13946, 15066, 15067, 15200, 15278, 16561, 17187, 17194
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: DES-15.023, DES-15.068, DES-15.069, DES-15.074, DES-15.075, DES-15.076, DES-15.087, DES-15.088, DES-15.089, DES-16.023, DES-16.068, DES-16.069, DES-16.070, DES-16.074, DES-16.075, DES-16.076, DES-16.082, DES-16.087, DES-16.088, DES-16.089
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?
This recall involves various BioHorizons Canada medical devices sold in Canada. They are being recalled because they were imported and distributed without being licensed by Health Canada. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model and lot numbers if provided. Return the product as instructed.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on October 30, 2020.
Is the BioHorizons Canada brand affected by this recall?
Yes, BioHorizons Canada products are affected by this recall. This recall involves various BioHorizons Canada medical devices sold in Canada. They are being recalled because they were imported and distributed without being licensed by Health Canada. Stop using the product and follow the return steps in the official notice.