ORTOMA recalls Inserter Adapters with weld breakage risk. Affected models include OTD Straight REF 30-201 and others. Stop using if you own these medical devices.
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
ORTOMA is recalling several Inserter Adapter models due to a potential weld breakage that could cause the device to detach during hip implant surgery. This risk may lead to improper positioning of the hip implant cup, which could affect surgical outcomes.
The Inserter Adapter has a weld that can break between the pin and inserter holder. If this happens during hip implant surgery, the adapter may detach, causing the hip implant cup to be positioned incorrectly. This could lead to improper alignment of the implant and potential complications for the patient.
Orthopedic surgeons and medical professionals using these adapters during hip replacement surgeries. Patients receiving hip implants are at risk if the adapter fails during the procedure.
Check for model numbers 2001, 1001, 1003, or 1004 on the adapter. Look for UDI-DI codes starting with 07350137521019, 07350137520593, 07350137520081, or 07350137520098. These adapters were sold in the U.S. only.
Identify the model number (2001, 1001, 1003, or 1004) and UDI-DI code on the adapter to confirm if it's affected.
Reach out to Ortoma AB directly for further guidance on the recall and potential remedies.
The recall is due to a weld breakage between the pin and inserter holder of the Inserter Adapter, which could cause detachment during hip implant surgery.
Affected models include Inserter Adapter OTD Straight REF 30-201 (Model 2001), Inserter Adapter OTD Pinnacle Straight REF 30-202 (Model 1001), Reamer Adapter OTD REF 30-157 (Model 1003), and Inserter Adapter OTD REF 30-158 (Model 1004).
The recall does not require immediate stop use; however, affected users should check the model and UDI-DI code and contact Ortoma AB for guidance.
We’ve drafted a message you can send ORTOMA to request your refund or repair — edit it as you like.
Subject: Recall Z-2615-2025 — ORTOMA ORTOMA Hello, I own a ORTOMA that is covered by recall Z-2615-2025 from ORTOMA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
