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

Recall Z-3115-2017 — Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK cons

U.S. FDA — Device Enforcement · United States · 2017-06-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3115-2017
Date of alert: 2017-06-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Implant Direct Sybron Manufacturing, LLC
Product category: device
Product type: Devices

Reported risk: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.

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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