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U.S. Department of Health and Human Services

Class 2 Device Recall Ortoma Inserter Adapter OTD

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 Class 2 Device Recall Ortoma Inserter Adapter OTDsee related information
Date Initiated by FirmJuly 28, 2025
Date PostedSeptember 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2615-2025
Recall Event ID 97416
510(K)NumberK232140 K250086 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductOrtoma 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 tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.
Code Information 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.
Recalling Firm/
Manufacturer		 ORTOMA AB
Falkenbergsgatan 3
Goteborg Sweden
Manufacturer Reason
for Recall		Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce261 devices
DistributionWorldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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