ORTOMA AB: 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

Hazard

Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

Details from the source

Reason for recall: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. Distribution: Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden. Quantity: 261 devices Lot/code info: 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.

UPC codes

07350137521019, 07350137520593, 07350137520081, 07350137520098

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.