IsoTis is voluntarily removing two lots of Accell Connexus, a demineralised bone matrix putty indicated as a bone graft extender in the spine, because contact between a ball spring and the mixing container during manufacture may have left particles in the product. Health Canada posted the Type II recall on 10 November (recall date 27 October) and lists it as a dental device; no matching FDA recall has been posted yet.
- Type
- Recall
- Company
- IsoTis OrthoBiologics (SeaSpine / Orthofix)
- Device
- Accell Connexus DBM putty, lots 2067034-1 (02-3000-010, 1 cc) and 1037800-1 (02-3000-025, 2.5 cc)
- Date
- 27 October 2026
- Jurisdiction
- CA
- Classification
- Health Canada Type II recall (RA-82936)
- Source
- Health Canada Recalls and Safety Alerts
Read the official notice →Source checked
What to do
Act on the regulator's or manufacturer's own notice; this page is a summary, not an official safety channel. If a device has failed or harmed a patient, see Report a Device Problem for who to tell in your country.