Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Ins

FDA device recall Z-2615-2025 · posted 2025-09-22 · Open, Classified

Recall details

Recalling firm

ORTOMA AB

Reason for recall

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

Action taken

On 07/28/2025, the firm sent via email an "URGENT: MEDICAL DEVICE FIELD CORRECTION" Letter to customers informing them that the Insert Adapter OTD Straight pin may partially or completely break. This malfunction, if not identified, may result in displaying incorrect information of the reaming or cup placement by OTS Hip Guide. The values displayed on the screen may not correctly represent the actual angle and position of the tool. The magnitude of the resulting error can vary and depends on the level of the weld breakage. Customers are instructed to: 1. Discontinue use and quarantine affected units until the instructions in this letter have been read, understood and acknowledged. Complete and return the attached form via email to support@ortoma.com. 2. Adhere to the following instructions: "Visual inspection: Inspect the device prior, during, and after surgery, for damages to the weld, see section visual inspection. "In case of partial or complete weld breakage, either use a replacement adapter or revert to conventional surgery. -Refer to IFU for recalibration procedure. Recalibration would lead to a slight delay in navigated surgery, estimated less than 3 minutes. -The consequence of reverting to conventional surgery would be that the user would not have the benefits of a navigated surgery. "If product should fail, ensure that item is cleaned and sterilized according to instructions and file a formal complaint. Visual inspection Inspect all affected devices to ensure that there are no visible cracks or scratches and that the pin is fixed. (Inspect the weld at a distance of around 40 cm.) -Inspect the devices prior to, during, and after surgery, see Figure 2. -A weld passes visual inspection if the pin is not possible to move and there are no visible cracks in the weld (Figure 2-a). -A weld fails the visual inspection if it is possible to move the pin and/or if there are visible cracks or breakage. For questions contact Ortoma at support@ortoma.com

Root cause

Process control

Status

Open, Classified

Product code

OLO

Quantity affected

261 devices

Distribution

Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.

Date initiated

2025-07-28

Date posted

2025-09-22

Location

Goteborg, Sweden

Related 510(k) clearances