Ortoma Inserter Adapter (Ortoma) – weld breakage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be t
Brand
ORTOMA AB Falkenbergsgatan 3 Goteborg Sweden
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
ORTOMA AB Falkenbergsgatan 3 Goteborg Sweden is recalling Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code due to Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026