Food, drugs, devices › XTANT MEDICAL INC
Device recall: OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(
FDA enforcement event 85036 is a device recall by XTANT MEDICAL INC of Belgrade, MT, initiated 3 May 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 17 Dec 2020. Initiation: voluntary: firm initiated. XTANT MEDICAL INC has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
XTANT MEDICAL INC, Belgrade, MT.
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."
Distribution
"US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1526-2020 | 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… | 26 | Class II | Terminated | 25 Mar 2020 |
Context
Other enforcement events for XTANT MEDICAL INC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Dec 2018 | Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF | Device | Class II | 1 |
| 12 Apr 2017 | 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece | Device | Class II | 1 |
All 3 events for XTANT MEDICAL INC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Dec 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.