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

Recall Z-1326-2016 — Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic

U.S. FDA — Device Enforcement · United States · 2016-02-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1326-2016
Date of alert: 2016-02-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes (USA) Products LLC
Product category: device
Product type: Devices

Reported risk: Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.

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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