Device recall

Z-0104-2009: Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of…

FDA device recall · Class II · Bausch & Lomb Inc

Key facts

Recall number (Z-number) Z-0104-2009
Recall event 47839
Product Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one of which is the maxon motor. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.
Product code HNO
Recalling firm Bausch & Lomb Inc
Recall class Class II
Status Terminated
Termination date Apr 2, 2012
510(k) numbers K040204
FEI number 1317628

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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

Browse all FDA device recalls (products)