Device recall

Z-2095-2020: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left…

FDA device recall · Class II · Howmedica Osteonics Corp.

Key facts

Recall number (Z-number) Z-2095-2020
Recall event 85583
Product Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
Product code LPH
Recalling firm Howmedica Osteonics Corp.
Recall class Class II
Status Terminated
Termination date Nov 15, 2021
510(k) numbers K151264
FEI number 3003070421

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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

Browse all FDA device recalls (products)