FDA Device Intelligence
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Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

FDA product code KWR · Class 3 · Orthopedic

0
Registered devices
170
Adverse events
1
Recalls
0
510(k) clearances

Recent recalls

DateFirmReason
2012-11-28The Anspach Effort, Inc.The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.