# FDA recall Z-2038-2020

> **Pega Medical Inc.** · Class III · device recall initiated 2020-04-03.

## 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.

## Reason for recall

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

## Distribution

US Nationwide Distribution including in the states of Florida.  No Foreign Consignees listed.

## Key facts

- **Recall number:** Z-2038-2020
- **Recalling firm:** Pega Medical Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-03
- **Report date:** 2020-05-27
- **Termination date:** 2020-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Laval, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2020

## Citation

> AI Analytics. FDA recall Z-2038-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2038-2020. Source: US FDA. Licensed CC0.

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