Device recall

Z-3082-2011: Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For…

FDA device recall · Class II · Tornier, Inc

Key facts

Recall number (Z-number) Z-3082-2011
Recall event 59399
Product Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to…
Product code JDB
Recalling firm Tornier, Inc
Recall class Class II
Status Terminated
Termination date Jul 17, 2012
510(k) numbers K100562
FEI number 3000718467

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)