Medical device recalls Moderate risk

Pega Medical Inc. recalls SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

Recall date
May 29, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2278-2019
FDA classification
Class II
Brand / firm
Pega Medical Inc.
Sold / distributed
CA, DE, FL, IL, NC, NE, NY and TN

Why it was recalled

Handle could jam with the Driver due to the detachment of an internal Connector Ring.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

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