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

Recall Z-0273-2014 — Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically control

U.S. FDA — Device Enforcement · United States · 2013-10-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0273-2014
Date of alert: 2013-10-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nobel Biocare Usa Llc
Product category: device
Product type: Devices

Reported risk: The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.

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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