Z-1526-2020Class II

OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R

Name: Z-1526-2020 OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R
Creator: Xtant Medical Inc
Published: 2019-05-03
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2019-05-03 / Terminated / root cause: labeling and UDI

FDA source

XTANT MEDICAL INC began a recall of OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI... on 2019-05-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1526-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Posted: 2020-03-19
Terminated: 2020-12-17
Recalling firm: Xtant Medical Holdings, Inc.
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.
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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: [email protected] Fax: 1-406-388-3380 3. Contact via email: [email protected], 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).
Quantity in commerce: 26
Distribution: US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees.
Product codes and lots: Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1526-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1526-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19

Product code MBP

K130498Class IIOsteoselect Demineralized Bone Matrix PuttyBacterin International, Inc. / cleared 2013-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)