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

Recall Z-1353-2015 — Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

U.S. FDA — Device Enforcement · United States · 2015-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1353-2015
Date of alert: 2015-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Orthovita, Inc., dBA Stryker Orthobiologics.
Product category: device
Product type: Devices

Reported risk: Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.

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

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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.

Recall Z-1353-2015 — Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

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