OsteoSelect Demineralized Bone Matrix — Class II medical device recall Z-1526-2020
Terminated recall by XTANT MEDICAL INC, reported 2020-03-25, distributed nationwide. The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices
| Recall number | Z-1526-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTANT MEDICAL INC, Belgrade, MT, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2020-03-19 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2020-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 26 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00849777003681 |
| Serial numbers | B180228-751 |
Product
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.
Reason for recall
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1526-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.