Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2038-2020 — 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.

U.S. FDA — Device Enforcement · Canada · 2020-04-03 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2038-2020
Date of alert
2020-04-03
Country / jurisdiction
Canada
Risk level
Class III
Risk type
recall
Brand
Pega Medical Inc.
Product category
device
Product type
Devices
Reported risk: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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