Device recall

Z-3201-2026: ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…

FDA device recall · Class II · Howmedica Osteonics Corp.

Key facts

Recall number (Z-number) Z-3201-2026
Recall event 99558
Product ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED…
Product code KWZ
Recalling firm Howmedica Osteonics Corp.
Recall class Class II
Status Open, Classified
510(k) numbers K261624
FEI number 3003070421

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 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)