Class 2 Device Recall OsteoSelect Demineralized Bone Matrix (DBM) Putty

• Date Initiated by Firm: May 03, 2019
• Create Date: March 19, 2020
• Recall Status: Terminated on December 17, 2020
• Recall Number: Z-1526-2020
• Recall Event ID: 85036
• 510(K)Number: K130498
• Product Classification: Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
• 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.
• Code Information: Lot/Serial numbers: B180228-751 through B180228-779;Model/Product Code: 359100;the expiration date of these devices is 2021-06-05.
• Recalling Firm/ Manufacturer: XTANT MEDICAL INC; 664 Cruiser Ln; Belgrade MT 59714-9719
• For Additional Information Contact: Michele Dolan; 406-388-0480
• Manufacturer 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.
• FDA Determined 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: 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).
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MBP and Original Applicant = BACTERIN INTERNATIONAL INC.