--- title: "IsoTis OrthoBiologics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search IsoTis OrthoBiologics, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/isotis-orthobiologics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # IsoTis OrthoBiologics, Inc. recall records **3** reported ongoing 3 records in this archive. Latest source date Jul 2, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 2, 2026 FDA device enforcement ### [OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095](https://isitonrecall.com/recall/fda-device-z-2820-2026-osteoballast-45-x-17-5-mm-seaspine-brand-ref-56800095-ballast-45-x-17-5-mm-isotis-brand-ref-02-8000/) 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 ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH. [Official source for OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand),...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2820-2026%22) Nov 27, 2024 FDA device enforcement ### [OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.](https://isitonrecall.com/recall/fda-device-z-0919-2025-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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX. [Official source for OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0919-2025%22) Nov 27, 2024 FDA device enforcement ### [OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.](https://isitonrecall.com/recall/fda-device-z-0955-2025-osteosurge-100-demineralized-bone-matrix-putty-with-accell-bone-matrix-osteosurge-100-demineralized/) Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. Class II Reported ongoing Distribution: US Nationwide distribution in the states of IN, TN & TX. [Official source for OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Deminerali...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0955-2025%22) ## Reasons in these listed records - 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 con... - Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. - Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. These examples come from this result page and are not a ranking of every recall reason. ## Checking IsoTis OrthoBiologics, Inc. ### Is there a recall on isotis orthobiologics, inc. right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search IsoTis OrthoBiologics, Inc.](https://isitonrecall.com/check/?q=IsoTis%20OrthoBiologics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)