FDA Medical Device Recalls (openFDA)
Straumann USA LLC: Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- Recall number
- Z-1632-2026
- Recalling firm
- Straumann USA LLC
- Product
- Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- Status
- Open, Classified
- Initiated
- 2026-03-17
- Posted
- 2026-03-24
- Terminated
- not on file
- Reason
- 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
- 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 jennifer.jackson@straumann.com 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 jennifer.jackson@straumann.com 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
- 13 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.
- Lot, serial or model codes
- Catalog Number/Art.: 027.4620; UDI-DI: 07630031713766; Order number (lot): 92465US_12039_00_b00 , 92465US_12040_00_b00 , 92465US_12047_00_b00 , 92465US_12048_00_b00 , 70959US_02227_00_b00 , 94021US_02348_00_b00, 70416US_07543_00_b00 , 91395US_01687_00_b00 , 91545US_03284_00_b00 , 91545US_03285_00_b00 , 71711US_00420_00_b00 , 91853US_06313_00_b00 , 72747US_00247_00_b00;
- 510(k) numbers
- ["K072151"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28