Device recall

Z-1134-2015: Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in…

FDA device recall · Class II · Zimmer Gmbh

Key facts

Recall number (Z-number) Z-1134-2015
Recall event 70401
Product Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments…
Product code LZO
Recalling firm Zimmer Gmbh
Recall class Class II
Status Terminated
Termination date Sep 23, 2015
510(k) numbers K071535
FEI number 3005233524

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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