IsoTis OrthoBiologics, Inc. recalls
Every recall we track for IsoTis OrthoBiologics, Inc. — 3 in all, from 2024–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for IsoTis OrthoBiologics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled IsoTis OrthoBiologics, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All IsoTis OrthoBiologics, Inc. recalls
3 shown- Lower riskMedical device
IsoTis OrthoBiologics, Inc. recalls OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
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.
IsoTisJul 2, 2026 - Lower riskMedical device
IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis recalls OsteoCove and Cove Putty products due to hydration issues making the putty less cohesive and moldable than intended. Affected items have specific reference numbers and expiration dates.
IsoTisNov 27, 2024 - Lower riskMedical device
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,
IsoTis recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration date listed on the outer box compared to inner tray. This could lead to using expired product.
IsoTisNov 27, 2024
IsoTis OrthoBiologics, Inc. recall questions
How many recalls has IsoTis OrthoBiologics, Inc. had?
3 recalls from IsoTis OrthoBiologics, Inc. are on record with U.S. safety agencies, from 2024–2026.
What is the most recent IsoTis OrthoBiologics, Inc. recall?
IsoTis OrthoBiologics, Inc. recalls OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095, dated Jul 2, 2026. Every IsoTis OrthoBiologics, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled IsoTis OrthoBiologics, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new IsoTis OrthoBiologics, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.