Z-2615-2025Class II

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

Name: Z-2615-2025 Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code...
Creator: Ortoma Ab
Published: 2025-07-28
License: https://open.fda.gov/license/

Ortoma AB / initiated 2025-07-28 / Open, Classified / root cause: manufacturing process

FDA source

ORTOMA AB began a recall of Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF... on 2025-07-28. FDA classified it as Class II and gives the reason as "Due to a weld breakage between the pin and inserter holder of the Inserter Adapter". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2615-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-28
Posted: 2025-09-22
Recalling firm: Ortoma AB
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 tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. 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 [email protected]
Quantity in commerce: 261 devices
Distribution: Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2615-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2615-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-22

Product code OLO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)