Recall Z-2820-2026
- Recall number
- Z-2820-2026
- Event number
- 99332
- Firm
- IsoTis OrthoBiologics, Inc.
- Firm FEI
- 3001503333
- Product code
- MQV
- Status
- Open, Classified
- Initiated
- 2026-07-02
- Posted
- 2026-07-28
- Root cause
- Process control
- 510(k) numbers
- K172130, K173424, K081227, K111838, K070220, K112857, K030266, K162860, K032288, K180758, K001724, K200752, K090177, K181585, K240442, K212991, K120354, K062495, K052494, K050357, K233566, K040381, K260364, K051914, K063359, K081439, K112383, K072170, K091912, K150621
Product#
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Reason for Recall#
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.