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Consensus Hip System
Shalby Advanced Technologies, Inc. · Model 1703-0-0050 · UDI-DI 00840286808477
JDL
Prescription
10
510(k) clearances
3,884
Adverse events (7 deaths)
4
Recalls
49
Facilities
Description
Acetabular Shell, Cementless, PC, 50mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-06-07 | Wright Medical Technology Inc | The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization m |
| 2009-05-14 | Wright Medical Technology Inc | Incorrect packaging, swapped sizes |
| 2009-05-14 | Wright Medical Technology Inc | Incorrect packaging, swapped sizes |
| 2004-01-09 | Stryker Howmedica Osteonics | This device is not approved for sale in the US. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
