Health product recall

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

Last updated

Summary

Product
ACE Surgical Supply® PGA (Polyglycolic Acid) Absorbable Sutures & Absorbable Gut Sutures
Issue
Medical devices - Unauthorised device
What to do

Contact importer.

Audience
Healthcare

Affected products

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Ace Surgical Supply Co. Inc.

1034 Pearl Street, Brockton, Massachusetts, United States, 02301

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81857

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