Z-1633-2026Class II

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438

Name: Z-1633-2026 Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438
Creator: Straumann USA LLC
Published: 2026-03-17
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2026-03-17 / Open, Classified / root cause: manufacturing process

FDA source

Straumann USA LLC began a recall of Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438 on 2026-03-17. FDA classified it as Class II and gives the reason as "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...". 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-1633-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-17
Posted: 2026-03-24
Recalling firm: Straumann USA, LLC
Product: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 7 units
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 codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1633-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1632-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-24
Z-1633-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-24

Product code NHA

K243278Class IICustom AbutmentsInstitut Straumann AG / cleared 2025-02-21

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)