DePuy Orthopaedics, Inc. recalls P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
- Recall date
- July 18, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2949-2018
- FDA classification
- Class II
- Brand / firm
- DePuy Orthopaedics, Inc.
- Sold / distributed
- The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
Why it was recalled
This unit may be missing the screw/collet Assembly
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
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