CanadaACE Surgical Supply® PGA (Polyglycolic Acid) absorbable sutures and various ACE Surgical Supply absorbable gut and related sutures are affected; they are identified by multiple catalogue numbers and all lots (for example 0034930, 0032498, 0032485, 0032482, 0032494, 0032480, 0032493, 0032504, 0032481, 0032499, 003-2489, 0030043, 0032484, 0032483, 32490, 0034960, 0034220). The recall was initiated because the manufacturer voluntarily ceased operations and discontinued its medical device licences in Canada, leaving unlicensed devices on the market; there is no known safety issue with the devices. Contact the importer, BioHorizons Canada.
What's being recalled
Companies: Ace Surgical Supply Co. Inc., 1034 Pearl Street, Brockton, Massachusetts, United States, 02301.
How to identify it
Affected products: 5/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0034930
Affected products: 4/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032498
Affected products: 4/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032485
Affected products: 4/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032482
Affected products: 4/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032494
Affected products: 3/0 Plain Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032480
Affected products: 3/0 Plain Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032493
Affected products: 3/0 Plain Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032504
Affected products: 3/0 Plain Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032481
Affected products: 5/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032499
Affected products: 4/0 Silk Black Braided Non Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 003-2489
Affected products: 3/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0030043
Affected products: 3/0 Chromic Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032484
Affected products: 4/0 Plain Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0032483
Affected products: 5/0 Plain Gut Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 32490
Affected products: 4/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0034960
Affected products: 4/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures; Lot or serial number: All lots.; Model or catalogue number: 0034220
The hazard
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.
What to do
Contact importer.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)