Device recall

Z-2038-2020: Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary…

FDA device recall · Class III · Pega Medical Inc.

Key facts

Recall number (Z-number) Z-2038-2020
Recall event 85531
Product Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Product code LXH
Recalling firm Pega Medical Inc.
Recall class Class III
Status Terminated
Termination date Nov 20, 2020
FEI number 3000327445

At a glance

  • None 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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