Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 th

U.S. FDA — Device Enforcement · United States · 2019-05-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1526-2020
Date of alert: 2019-05-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: XTANT MEDICAL INC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00849777003681

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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