Device recall

Z-0107-04: 17 mm thickness only of a polyethelene insert, which sits on the top of a metal…

FDA device recall · Class II · Plus Orthopedics

Key facts

Recall number (Z-number) Z-0107-04
Recall event 27053
Product 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
Product code KRO
Recalling firm Plus Orthopedics
Recall class Class II
Status Terminated
Termination date Dec 12, 2004
FEI number 3001237832

At a glance

  • None 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

Browse all FDA device recalls (products)