Safety Alert: Class II: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
healthClass IIRecalled on Oct 1, 2025
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnac
🔢 261 devices
Sold At: ORTOMA AB(Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.)
Recall #: FDA-DEVICE-Z-2615-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model Number: 2001 Catalog Number: 30-201 UDI-DI code: 07350137521019 Lot Numbers: 20244803 Model Number: 1001 Catalog Number: 30-202 UDI-DI code: 07350137520593 Lot Numbers: 20245103 20245104 20245109 Model Number: 1003 Catalog Number: 30-157 UDI-DI code: 07350137520081 Lot Numbers: 20242001 20242008 20245119 Model Number: 1004 Catalog Number: 30-158 UDI-DI code: 07350137520098 Only distributed O.U.S.
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Summary
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact ORTOMA AB for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.