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

Recall Z-0967-2018 — SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056

U.S. FDA — Device Enforcement · United Kingdom · 2017-10-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0967-2018
Date of alert: 2017-10-10
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: ORTHO SOLUTIONS, LTD.
Product category: device
Product type: Devices

Reported risk: Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.

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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