Isotis Orthobiologics, Inc.: Osteoballast, 45 X 17.5 Mm (seaspine Brand), Ref: 56800095. Ballast, 45 X 17.5 Mm (isotis Brand), Ref: 02-8000-095
Recall Summary IsoTis OrthoBiologics is recalling OsteoBallast and Ballast bone graft products (specific model sizes and reference numbers listed) used in spine and pelvis surgery because some units were filled with insufficient bone matrix material—about 4.5 cc instead of the required 7.5 cc. This underfill may result in delayed, incomplete, or failed bone fusion after surgery. The products were distributed nationwide across multiple states.
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Product
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/02ea87f9-3e72-445a-8849-1a2e058d5430