The Recall Desk
HighFDA (Devices)·Z-2289-2025·Announced 2025-08-20

[pending] Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

Pending LLM rewrite. Source: FDA_DEVICE Z-2289-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Inconsistent size terminology and color coding used on labeling

The recalled product

Product
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)

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 (2)

  • Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168
  • C424053

Distribution

Distributed nationwide across the United States.