Straumann USA LLC: WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Straumann USA LLC
- Product
- WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- Reason / hazard
- The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-01-06
- Code info
- Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
- Product quantity
- 561 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Andover
- State
- MA
- Country
- United States
- Event id
- 98265
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