OsteoBallast, 45 x 17
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.
- Agency
- FDA Device
- Recall date
- Jul 2, 2026
- Status
- Ongoing
- Company
- IsoTis OrthoBiologics, Inc.
1. What product was recalled?
OsteoBallast, 45 x 17
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Quantity: 98
Code or lot text: REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
- LOT
- 181550
- LOT
- 181550 02-8000-095/10889981149314/181559
- LOT
- REF/UDI-DI/Lots: 56800095/10889981149352/181559
- RECALL-NUMBER
- Z-2820-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Alaska: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Arkansas: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- California: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- New Jersey: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Ohio: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Tennessee: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Washington: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.