IsoTis recalls OsteoBallast 45x17.5mm implants that may cause delayed or failed spinal fusion due to incorrect bone matrix fill. Affected units have specific reference numbers.
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
IsoTis recalls certain OsteoBallast spinal implants that contain too little demineralized bone matrix (DBM) than specified. This could lead to delayed or failed spinal fusion, causing pain and requiring additional surgery.
The implants contain approximately 4.5 cc of DBM instead of the required 7.5 cc. This incorrect fill amount may result in the bone not fusing properly, leading to delayed healing, incomplete fusion, or the need for additional surgery.
Patients who received the recalled OsteoBallast implants for spinal fusion procedures. Those with the specific reference numbers listed in the recall are most at risk.
Check for the product name 'OsteoBallast' with size 45 x 17.5 mm. The reference numbers include 56800095 for SeaSpine Brand and 02-8000-095 for IsoTis Brand.
Identify the reference number on the implant packaging or label to confirm if it matches the recalled units.
The implants contain too little demineralized bone matrix (DBM) than specified, which may lead to delayed or failed spinal fusion.
Check the reference number on the implant packaging to see if it matches the recalled units. If it does, contact the manufacturer for further instructions.
Using the recalled implants may cause delayed fusion, incomplete fusion, or lack of bone growth, potentially requiring additional surgery.
We’ve drafted a message you can send IsoTis to request your refund or repair — edit it as you like.
Subject: Recall Z-2820-2026 — IsoTis IsoTis Hello, I own a IsoTis that is covered by recall Z-2820-2026 from IsoTis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
