Z-1337-2026Class III

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

Name: Z-1337-2026 WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Creator: Straumann USA LLC
Published: 2026-01-06
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2026-01-06 / Open, Classified / root cause: packaging

FDA source

Straumann USA LLC began a recall of WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM on 2026-01-06. FDA classified it as Class III and gives the reason as "The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1337-2026
Classification: Class III
Status: Open, Classified
Initiated: 2026-01-06
Posted: 2026-02-09
Recalling firm: Straumann USA, LLC
Product: WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On January 6, 2026 Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Check your inventory for the affected article/lot 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 WB Impression Post Closed Tray, no action regarding patient treatment is required. 5. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 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: 561 units
Distribution: US Nationwide distribution.
Product codes and lots: Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1337-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1337-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)