Quality & complianceOfficial

Health Canada lists Type II recall of two Accell Connexus lots over particulate risk

🇨🇦 Health Canada · Tue 10 Nov 2026

IsoTis OrthoBiologics is voluntarily removing specific Accell Connexus lots in Canada after possible particulate contamination linked to contact between a ball spring and the mixing container during manufacture.

Health Canada has published a Type II recall of Accell Connexus, a product from IsoTis OrthoBiologics, Inc. The notice, updated on 10 November 2026, carries identification number RA-82936 and gives a recall date of 27 October 2026.

The agency describes the action as a voluntary product removal. The stated cause is potential particulate contamination arising from contact between the ball spring and the mixing container during manufacturing. The notice classifies the issue as a medical device performance problem.

Two lots are affected. Lot 2067034-1 corresponds to catalogue number 02-3000-010, and lot 1037800-1 to catalogue number 02-3000-025. Health Canada says the affected products were distributed in Canada. The listing places the product in the medical devices category, under dental.

The notice is addressed to industry. Its only advice is to contact the manufacturer for additional information. The company is listed at 2 Goodyear, Irvine, California, United States. The notice gives no details on injuries, complaints or the quantities involved.

As general context, Health Canada uses a Type II classification where use of or exposure to a product may cause temporary or medically reversible adverse effects, or where the likelihood of serious adverse health consequences is remote.

What it means for your team

  • Check Canadian inventory and distribution records against lots 2067034-1 (02-3000-010) and 1037800-1 (02-3000-025).
  • Contact IsoTis OrthoBiologics for recall instructions, as the notice offers no further guidance on handling affected stock.
  • Manufacturing teams may wish to note the cited root cause, contact between the ball spring and the mixing container, when reviewing particulate controls.
  • The notice does not say whether other markets are affected, so teams outside Canada should seek confirmation from the manufacturer.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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