Device recall

Z-1306-2018: A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number…

FDA device recall · Class II · Zimmer Biomet, Inc.

Key facts

Recall number (Z-number) Z-1306-2018
Recall event 79393
Product A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Product code HRS
Recalling firm Zimmer Biomet, Inc.
Recall class Class II
Status Terminated
Termination date May 1, 2020
510(k) numbers K093474, K111663
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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