Device recall

Z-1137-2007: Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device…

FDA device recall · Class III · Encore Medical, Lp

Key facts

Recall number (Z-number) Z-1137-2007
Recall event 37878
Product Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758.
Product code LKH
Recalling firm Encore Medical, Lp
Recall class Class III
Status Terminated
Termination date Mar 27, 2008
FEI number 1000116912

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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