Recall Z-1526-2020— XTANT MEDICAL INC

Name: FDA recall Z-1526-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-03

Class II · Terminated

Class II FDA medical device recall by XTANT MEDICAL INC, initiated 2019-05-03, terminated 2020-12-17. It names one FDA 510(k) clearance: K130498. 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: 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..

Recalling firm: XTANT MEDICAL INC
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Terminated: 2020-12-17
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K130498 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.·cleared 2013-05-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.