Straumann USA LLC Recalls WB Impression Post Closed Trays Due to Component Mix-Up

FDA Recalls low FDA · · United States

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 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.

Source: FDA Official Notice