Reported Oct 1, 2025 · Ongoing
Ortoma Inserter Adapter OTD
Ortoma Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ORTOMA AB · Falkenbergsgatan 3 · Goteborg, N/A · N/A
Is this the product you have?
Ortoma Inserter Adapter OTD
8 of 8 products
| Model / number | Barcodes | Product as published |
|---|---|---|
30-201 | — | |
2001 | 07350137521019 | UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight |
30-202 | — | |
1001 | 07350137520593 | UDI-DI code: 07350137520593 Reamer Adapter OTD |
30-157 | — | |
1003 | 07350137520081 | UDI-DI code: 07350137520081 Inserter Adapter OTD |
30-158 | — | |
1004 | 07350137520098 | 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. |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published 30-20107350137521019Model Number: 2001 UDI-DI code: 07350137521019 — Lot Numbers: 20244803 30-20207350137520593Model Number: 1001 UDI-DI code: 07350137520593 — Lot Numbers: 20245103 20245104 20245109 30-15707350137520081Model Number: 1003 UDI-DI code: 07350137520081 — Lot Numbers: 20242001 20242008 20245119 30-15807350137520098Model Number: 1004 UDI-DI code: 07350137520098 Only distributed O.U.S. - Amount recalled
- 261 devices
Where it was sold
- Nationwide
- FL
Why it was recalled
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
This product could cause temporary or reversible health problems — stop using it.
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