Device recall

Z-1987-2025: Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat…

FDA device recall · Class II · Preat Corp

Key facts

Recall number (Z-number) Z-1987-2025
Recall event 96671
Product Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
Product code NHA
Recalling firm Preat Corp
Recall class Class II
Status Open, Classified
510(k) numbers K183518
FEI number 2918719

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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