Medical device recall in Canada: Missing French on implant card
In plain language
This recall involves various Unipolar Adapters, Bi Polar Adapters, Cap and Sleeve Kits, and Bipolar Leads sold in Canada. They are being recalled because the implant cards only had English and were missing French. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Contact Greatbatch Medical for further instructions.
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Affected products
Unipolar adapter 5MM
Model: 501203
Lot: All lots
Unipolar adapter 6MM
Model: 501204
Lot: All lots
Bi Polar Adapter
Model: 501205
Lot: All lots
Bipolar adapter dual port
Model: 501206
Lot: All lots
Bipolar adapter, short
Model: 501214
Lot: All lots
Cap and Sleeve Kit
Model: 501207
Lot: All lots
Bipolar lead, 25CM
Model: 511210
Lot: All lots
Bipolar lead, 54CM
Model: 511211
Lot: All lots
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: 501203, 501204, 501205, 501206, 501207, 501214, 511210, 511211
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 Unipolar Adapters, Bi Polar Adapters, Cap and Sleeve Kits, and Bipolar Leads sold in Canada. They are being recalled because the implant cards only had English and were missing French. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Contact Greatbatch Medical for further instructions.
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 September 17, 2018.