Health Products

ACE Surgical Supply® PGA (Polyglycolic Acid) Absorbable Sutures & Absorbable Gut Sutures

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: ACE Surgical Supply® PGA (Polyglycolic Acid) Absorbable Sutures & Absorbable Gut Sutures
Issue: Medical devices - Unauthorised device
What to do: Contact importer.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
5/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable SuturesAll lots.0034930
4/0 Chromic Gut Absorbable SuturesAll lots.0032498
4/0 Chromic Gut Absorbable SuturesAll lots.0032485
4/0 Chromic Gut Absorbable SuturesAll lots.0032482
4/0 Chromic Gut Absorbable SuturesAll lots.0032494
3/0 Plain Gut Absorbable SuturesAll lots.0032480
3/0 Plain Gut Absorbable SuturesAll lots.0032493
3/0 Plain Gut Absorbable SuturesAll lots.0032504
3/0 Plain Gut Absorbable SuturesAll lots.0032481
5/0 Chromic Gut Absorbable SuturesAll lots.0032499
4/0 Silk Black Braided Non Absorbable SuturesAll lots.003-2489
3/0 Chromic Gut Absorbable SuturesAll lots.0030043
3/0 Chromic Gut Absorbable SuturesAll lots.0032484
4/0 Plain Gut Absorbable SuturesAll lots.0032483
5/0 Plain Gut Absorbable SuturesAll lots.32490
4/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable SuturesAll lots.0034960
4/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable SuturesAll lots.0034220

Issue

BioHorizons Canada is performing a recall for products manufactured by ACE Surgical. This recall is due to the fact that the manufacturer has voluntarily ceased operations for commercial reasons, and has discontinued its medical device licenses in Canada; resulting in the presence of unlicensed devices on the market. There is no known safety issue with the devices in question, the licenses were canceled for commercial reasons. As an importer, BioHorizons Canada will perform this correction for customers to whom it has distributed affected product.

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