Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Ho
FDA device recall Z-0468-2008 · posted 2007-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Mis-labeling; The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
- Action taken
- Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 105
- Distribution
- Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
- Date initiated
- 2007-09-28
- Date posted
- 2007-12-14
- Date terminated
- 2008-10-27
- Location
- Mahwah, NJ
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