Custom Abutment AS Ti, for Straumann RC, incl. TAN screw recallZ-1633-2026 · Straumann USA LLC · initiated Mar 17, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
FDA root cause category: Process control
What the company is doing
On March 17, 2026, Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. Check your inventory for the affected article/project numbers. 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If you have used the custom abutment, no action regarding patient treatment is required. Complete the Customer Confirmation Form indicating the product has been used. Should you determine that a remake is warranted, please contact Jennifer Jackson at [email protected] to arrange for a remake. 6. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to [email protected] This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred.
Recall details
- Recall number
- Z-1633-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 17, 2026
- Posted by the FDA
- Mar 24, 2026
- Recalling firm
- Straumann USA LLC
- Quantity
- 7 units
- Product code
- NHA
- FDA submissions
- K243278
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.
Product description
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Code information (models, lots, serial numbers)
Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98565).
- Z-1632-2026 · Open, ClassifiedCustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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