Device recall

Z-2967-2018: Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis…

FDA device recall · Class II · Encore Medical, Lp

Key facts

Recall number (Z-number) Z-2967-2018
Recall event 80692
Product Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Product code JWH
Recalling firm Encore Medical, Lp
Recall class Class II
Status Terminated
Termination date Aug 17, 2020
FEI number 1000116912

At a glance

  • None 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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