ACE Surgical Supply® PGA (Polyglycolic Acid) Absorbable Sutures & Absorbable Gut Sutures
Brand(s)
Summary
Contact importer.
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
Ace Surgical Supply Co. Inc.
1034 Pearl Street, Brockton, Massachusetts, United States, 02301
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