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Consensus Hip System

Shalby Advanced Technologies, Inc. · Model 1704-0-0068 · UDI-DI 00840286808705

JDL Prescription
10
510(k) clearances
3,884
Adverse events (7 deaths)
4
Recalls
49
Facilities

Description

Acetabular Shell, No Hole, Cementless, PC, 68mm

Recalls

DateFirmReason
2010-06-07Wright Medical Technology IncThe inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization m
2009-05-14Wright Medical Technology IncIncorrect packaging, swapped sizes
2009-05-14Wright Medical Technology IncIncorrect packaging, swapped sizes
2004-01-09Stryker Howmedica OsteonicsThis device is not approved for sale in the US.

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Data 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.