Device recall

Z-1060-2009: PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the…

FDA device recall · Class II · Medtronic Neuromodulation

Key facts

Recall number (Z-number) Z-1060-2009
Recall event 50856
Product PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, Manufactured at Medtronic, Inc Villalba, Puerto Rico. Indicated for the…
Product code KNS
Recalling firm Medtronic Neuromodulation
Recall class Class II
Status Terminated
Termination date May 17, 2012
510(k) numbers K052413
FEI number 2182207

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

Browse all FDA device recalls (products)