IsoTis OrthoBiologics pulls two Accell Connexus dental lots in Canada over manufacturing issue

IsoTis OrthoBiologics is taking two production lots of its Accell Connexus dental product off the Canadian market, according to a notice Health Canada updated on 10 November 2026. The company began the withdrawal on 27 October 2026, and the regulator filed it as a Type II recall under reference RA-82936.

The notice does not quantify the commercial exposure. It gives no unit counts, no sales value and no information on how much of the affected stock was already used or remains with customers. It also says nothing about injuries or complaints, so the size of any revenue or reputational effect cannot be judged from the public record.

The cause the agency cites sits in manufacturing: during production, the ball spring is said to have touched the mixing vessel, which could have left stray particles in the product. Health Canada classes the matter as a performance problem for a medical device, and lists the product under dental devices.

The lots are identified as 2067034-1, catalogue number 02-3000-010, and 1037800-1, catalogue number 02-3000-025. The notice says both were distributed in Canada and is silent on other markets. The only instruction to industry is to contact the manufacturer, which is listed at 2 Goodyear, Irvine, California.

As general context rather than a finding about this case: Health Canada applies the Type II label where use of or exposure to a product may cause temporary or medically reversible adverse effects, or where the chance of serious harm is remote.