FDA Medical Device Recalls (openFDA)
Straumann USA LLC: WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- Recall number
- Z-1337-2026
- Recalling firm
- Straumann USA LLC
- Product
- WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- Status
- Open, Classified
- Initiated
- 2026-01-06
- Posted
- 2026-02-09
- Terminated
- not on file
- Reason
- The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- 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 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
- 561 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- 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