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

Recall Z-0534-2020 — Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, pa

U.S. FDA — Device Enforcement · United States · 2019-10-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0534-2020
Date of alert: 2019-10-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nextremity Solutions
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00817701022558

Reported risk: Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

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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