Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 1, 2025
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
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortoma Ab recalled Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 200… - a moderate-severity action.
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 200… was recalled by Ortoma Ab in October 1, 2025. Reason: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.. Check the official notice for the remedy. Verify recall #Z-2615-2025 with the FDA Devices before acting.
The recall
Ortoma Ab issued this moderate-severity FDA Devices recall-Due to a weld breakage between the pin and inserter holder of the Inserter Adapter..
- Moderate
- severity level
- 261 units
- affected scope
- Class II
- classification
- October 1, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2615-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2615-2025) was formally reported on October 1, 2025, with the manufacturer initiating the action on July 28, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ortoma Ab is listed as the recalling firm, operating out of Goteborg, N/A. Federal records list the affected scope as 261 devices.
The documented reason for this recall is: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
261 devices
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2615-2025 |
| Date reported | October 1, 2025 |
| Date initiated | July 28, 2025 |
| Recalling firm | Ortoma Ab |
| Firm location | Goteborg, N/A |
| Affected scope | 261 devices |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2615-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ortoma Ab. Units affected: 261 devices.
Why was this product recalled? ▼
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2025. Severity: Moderate. Recall number: Z-2615-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S. Nationwide distribution in the state of FL and the countries of Japan, Sweden..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2615-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 1, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.