Device recall

Z-2600-2018: Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP…

FDA device recall · Class II · Encore Medical, Lp

Key facts

Recall number (Z-number) Z-2600-2018
Recall event 80445
Product Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
Product code LRO
Recalling firm Encore Medical, Lp
Recall class Class II
Status Terminated
Termination date Aug 22, 2023
FEI number 1000116912

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1,000+ 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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