Device recall

Z-1614-2009: Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile…

FDA device recall · Class II · Biomet, Inc.

Key facts

Recall number (Z-number) Z-1614-2009
Recall event 52092
Product Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.
Product code LZO
Recalling firm Biomet, Inc.
Recall class Class II
Status Terminated
Termination date Oct 6, 2010
510(k) numbers K042091
FEI number 1825034

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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