Device recall

Z-0058-2015: Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments…

FDA device recall · Class II · Biomet, Inc.

Key facts

Recall number (Z-number) Z-0058-2015
Recall event 69360
Product Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Product code HXQ
Recalling firm Biomet, Inc.
Recall class Class II
Status Terminated
Termination date Jul 14, 2015
FEI number 1825034

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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