Device recall

Z-1237-2024: RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults…

FDA device recall · Class II · Synthes (USA) Products LLC

Key facts

Recall number (Z-number) Z-1237-2024
Recall event 93924
Product RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized…
Product code HTO
Recalling firm Synthes (USA) Products LLC
Recall class Class II
Status Open, Classified
510(k) numbers K013527, K042899, K111437
FEI number 3008812560

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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)