Dental impression posts recalled over caps in the wrong colour
Straumann USA is recalling 561 WB Impression Post Closed Tray units because the impression caps provided in the package are magenta instead of brown.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the cosmetic-defect criterion: the record cites impression caps supplied in the wrong colour, with no functional defect or stated consequence.
Plain-English summary
The WB Impression Post Closed Tray including guide screw, L 13mm, TAN/POM, is being recalled by Straumann USA LLC.
The reason given in the enforcement record is a mix up of the impression caps provided in the package: the provided impression caps are magenta instead of brown.
The record lists 561 units under article number 065.4810, UDI-DI 07630031741110, lot numbers VWPX4 and VWPX6. Distribution was nationwide in the United States. The FDA has classified the action as Class III, its least serious category.
The record cites a component colour mix-up and states no consequence or reported injuries. Facilities should follow Straumann's instructions.
The recalled product
- Product
- WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- Manufacturer
- Straumann USA LLC
- Affected units
- 561
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Article Number: 065.4810
- UDI-DI: 07630031741110
- Lot numbers: VWPX4
- VWPX6
Distribution
Distributed nationwide across the United States.
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