Device recall

Z-1665-2010: Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left…

FDA device recall · Class II · Biomet, Inc.

Key facts

Recall number (Z-number) Z-1665-2010
Recall event 55365
Product Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF 104773, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.
Product code LPH
Recalling firm Biomet, Inc.
Recall class Class II
Status Terminated
Termination date Oct 18, 2010
510(k) numbers K031693
FEI number 1825034

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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