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Spinal Frontiers · Regulatory Watch · Recall

Accell Connexus DBM putty lots withdrawn in Canada over particulate contamination

Recall · IsoTis OrthoBiologics (SeaSpine / Orthofix)

27 October 2026

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.

Other recalls

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