Straumann USA LLC Recalls WB Impression Post Closed Trays Due to Component Mix-Up
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Straumann USA LLC has issued a voluntary recall for 561 units of WB Impression Post Closed Trays after discovering that incorrect color-coded impression caps were included in the packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 25, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Straumann USA LLC has initiated a voluntary recall of specific WB Impression Post Closed Trays. The recall was prompted by a component mix-up within the product packaging. Specifically, the impression caps provided in the affected packages are magenta in color instead of the required brown.
Which Products Are Affected
The recall affects 561 units distributed nationwide across the United States. The specific details for the affected products are as follows:
- Product Name: WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- Article Number: 065.4810
- UDI-DI: 07630031741110
- Lot Numbers: VWPX4 and VWPX6
- Recall Number: Z-1337-2026
What You Should Do
The firm initiated the recall on January 6, 2026, and notified affected customers via a formal letter. Healthcare providers and distributors should immediately check their inventory for the specified lot numbers (VWPX4 and VWPX6). If the product contains magenta caps instead of brown, it should be handled according to the instructions provided in the firm's notification letter.
Why This Matters
This is a Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, the color-coding discrepancy is a deviation from product specifications that could lead to confusion during clinical procedures.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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