Device recall

Z-0972-2019: Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper…

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

Key facts

Recall number (Z-number) Z-0972-2019
Recall event 81118
Product Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed…
Product code KWS
Recalling firm Zimmer Biomet, Inc.
Recall class Class II
Status Terminated
Termination date May 6, 2020
510(k) numbers K120121
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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