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

Recall Z-1666-2013 — InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Sp

U.S. FDA — Device Enforcement · United States · 2013-05-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1666-2013
Date of alert: 2013-05-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: SpineFrontier, Inc.
Product category: device
Product type: Devices

Reported risk: Potential for set screw to be come deformed.

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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