Device recall

Z-0561-04: Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number…

FDA device recall · Class III · Pioneer Surgical Technology

Key facts

Recall number (Z-number) Z-0561-04
Recall event 28213
Product Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
Product code HWC
Recalling firm Pioneer Surgical Technology
Recall class Class III
Status Terminated
Termination date May 20, 2004
510(k) numbers K990804
FEI number 1000115331

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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