XTANT MEDICAL INC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
XTANT MEDICAL INC
Lot Codes / Batch Numbers
Lot/Serial numbers: B180228-751 through B180228-779, Model/Product Code: 359100, the expiration date of these devices is 2021-06-05.
Products Sold
Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.
XTANT MEDICAL INC is recalling OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 3591 due to The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 3, 2019 a customer letter (in an envelope marked URGENT) was Federal Expressed overnight-signature required to the 16 customers who received the 26 devices. The specific actions to be taken by the customer/user that were shipped the product affected by the recall are requested to do the following: 1. Immediately examine their inventory and quarantine any affected products subject to this recall. 2. Complete an enclosed Acknowledgement Form, even if they have no remaining devices in their inventory, and return the completed Acknowledgment Form via mail: Mail: DBM Recall 664 Cruiser Lane Belgrade, MT 59714 Email: mdolan@xtantmedical.com Fax: 1-406-388-3380 3. Contact via email: mdolan@xtantmedical.com, or 1-406-388-0480 ext. 1127, between 8 a.m. and 5 p.m. (Mountain Time) to obtain instructions for returning affected product, and to obtain replacement devices which will be provided at no cost. 4. Package the affected products to be returned. The firm will provide a shipping container (if needed) with a return shipping label. Securely package the affected product(s). Send the container to: ATTN: OSTEOSELECT DBM RECALL (RMA Number) 732 Cruiser Lane Belgrade, MT 59714 For questions, please contact the Director of RA/QA at 1-406-388-0480 ext. 1128, from 8 a.m. to 5 p.m. (Mountain Time).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026