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

Recall Z-2615-2025 — Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520

U.S. FDA — Device Enforcement · Sweden · 2025-07-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2615-2025
Date of alert
2025-07-28
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
ORTOMA AB
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07350137521019
Reported risk: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
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.

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