Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary Recalled by Pega Medical Inc. Due to The lot number on the pediatric orthopedic implant...

Date: April 3, 2020
Company: Pega Medical Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pega Medical Inc. directly.

Affected Products

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.

Quantity: 3 units

Why Was This Recalled?

The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pega Medical Inc.

Pega Medical Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report