FDAFDA · Food and drugs·Recall number Z-1160-2016
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
Published March 23, 2016 · Recall initiated: January 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Manufacturing B.V.
- Distributor
- US Nationwide Distribution
- Lot
- lot no.: 62313588
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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