# Major Recall Alert: BioHorizons Canada Recalls ACE Surgical Sutures Due to Licensing Issues
**BioHorizons Canada** has announced a significant recall for several suture products manufactured by ACE Surgical. Although there is no known safety issue with the affected medical devices, the recall is prompted by ACE Surgical's voluntary decision to cease operations for commercial reasons. As a result, the company has discontinued its medical device licenses in Canada, causing these products to be classified as unlicensed devices. BioHorizons Canada, as the importer, is taking corrective action and working to inform affected customers.
If you have purchased or distributed ACE Surgical sutures, here's everything you need to know about this recall, along with steps to ensure compliance and safety.
## Why This Recall is Important
The recall highlights a key regulatory matter: medical devices sold in Canada must have valid licenses from Health Canada to ensure compliance with national health and safety standards. Since ACE Surgical has discontinued its licensing for commercial reasons, several of their products now lack the necessary approval to be marketed in Canada.
While Health Canada has confirmed that **there are no known safety issues with the recalled devices**, this action ensures that unlicensed products are no longer distributed or used in medical applications. BioHorizons Canada's proactive response underscores the importance of maintaining regulatory compliance and protecting patient care.
## Details of the Recall
The following suture products are included in this recall:
- **3/0 Chromic Gut Absorbable Sutures**
- **3/0 Plain Gut Absorbable Sutures**
- **4/0 Chromic Gut Absorbable Sutures**
- **4/0 PGA (Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures**
- **4/0 Plain Gut Absorbable Sutures**
- **4/0 Silk Black Braided Non-Absorbable Sutures**
- **5/0 Chromic Gut Absorbable Sutures**
- **5/0 PGA (Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures**
- **5/0 Plain Gut Absorbable Sutures**
**Reason for Recall:** The recall is solely due to the voluntary cessation of ACE Surgical's operations and their discontinuation of medical device licenses in Canada. These products, therefore, do not meet current licensing requirements under Canadian law.
**Date Announced:** October 2023
**Safety Alert:** At this time, there are no reports of adverse events or safety concerns related to the products. However, unlicensed medical devices should not be used, as they do not meet regulatory standards.
## What You Should Do
If you currently possess or use any of the listed suture products, follow these steps immediately:
- **Discontinue Use:** Cease the use of any affected sutures listed in the recall.
- **Notify Customers or Patients:** If you have distributed these products, communicate the recall details to your downstream customers as required.
- **Contact BioHorizons Canada:** Reach out to the company for assistance with product returns and corrections.
- **Stay Updated:** Keep an eye on notifications from Health Canada and BioHorizons for further updates or specific instructions regarding the recall.
For specific guidance, you can refer to the official recall notification here: [Health Canada Official Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/ace-surgical-supplyr-pga-polyglycolic-acid-absorbable-sutures-absorbable-gut-sutures)
## Stay Safe – Get Instant Recall Alerts
Recalls like this emphasize the importance of staying informed about the medical devices and products you use or distribute. To protect your patients and stay proactive, sign up for instant product safety alerts. By downloading Health Canada’s official recall app, you can gain real-time recall updates directly to your phone.
**Act now to ensure compliance, safety, and peace of mind.** Stay ahead of product recalls by downloading the app today.