Device recall

Z-2827-2020: POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes…

FDA device recall · Class II · Smith & Nephew Orthopaedics AG

Key facts

Recall number (Z-number) Z-2827-2020
Recall event 86099
Product POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the…
Product code LZO
Recalling firm Smith & Nephew Orthopaedics AG
Recall class Class II
Status Open, Classified
510(k) numbers K143739
FEI number 3002807893

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

Browse all FDA device recalls (products)