# FDA recall Z-1526-2020

> **XTANT MEDICAL INC** · Class II · device recall initiated 2019-05-03.

## 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 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.

## Key facts

- **Recall number:** Z-1526-2020
- **Recalling firm:** XTANT MEDICAL INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-03
- **Report date:** 2020-03-25
- **Termination date:** 2020-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Belgrade, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1526-2020

## Citation

> AI Analytics. FDA recall Z-1526-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1526-2020. Source: US FDA. Licensed CC0.

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