IsoTis OrthoBiologics recalls
3 official recalls and safety alerts involving IsoTis OrthoBiologics since 2025-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with IsoTis OrthoBiologics or the relevant agency.
- 2026-08-05
USIsoTis 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
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…
FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.Official notice →- 2025-01-22
- US
IsoTis OrthoBiologics, Inc. recalls OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of IN, TN & TX.Official notice → - US
IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
FDA · DeviceIsoTis OrthoBiologics, Inc.US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH,…Official notice →