Medical device recall in Canada: Implants shipped without clearance
In plain language
This recall involves Vertical Mandibular Angle™ & Temporal Shell™ Implants and Composite™ EPTFE-Coated Extended Anatomical Chin sold in Canada. They are being recalled because they were shipped to Canada without appropriate market clearance. 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.
- Return the product as instructed.
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Affected products
Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Left
Model: VMA-7L
Lot: 886835
Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Right
Model: VMA-7R
Lot: 886441
Vertical Mandibular Angle (TM) Sizers
Model: VMA-SIZ-NS
Lot: 882810
Temporal Shell (TM) Implant-Size: 7mm, Left
Model: TS-07L
Lot: 885147
Temporal Shell (TM) Implant-Size: 7mm, Right
Model: TS-07R
Lot: 883066
Composite(TM) EPTFE-Coated Extended Anatomical Chin-Size: Small
Model: EPTFE-EAC-S
Lot: EPTFE-EAC-S
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: 882810, 883066, 885147, 886441, 886835, EPTFE-EAC-S
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: EPTFE-EAC-S, TS-07L, TS-07R, VMA-7L, VMA-7R, VMA-SIZ-NS
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 Vertical Mandibular Angle™ & Temporal Shell™ Implants and Composite™ EPTFE-Coated Extended Anatomical Chin sold in Canada. They are being recalled because they were shipped to Canada without appropriate market clearance. 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. 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 February 12, 2021.