Medical device recalls Moderate risk

DePuy Spine, Inc. recalls EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBE…

Recall date
April 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1674-2015
FDA classification
Class II
Brand / firm
DePuy Spine, Inc.
Sold / distributed
US: PA and OUS: SE, BE, IT, PT

Why it was recalled

Device does not mate as intended.

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

What was recalled

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

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