FDAFDA · Food and drugs·Recall number Z-1143-2016
Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 511007045 MGII KNEE SLF-TAP BONE ST for use in total knee 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.: 61814292 61817008 61920896 61953528 62021071 62021071N 61810760 61814293 61817010 61830536 61868946 61895893 61920897 61953529 62021042 62079774 62326383 61810761 61810762 61817013 61817014 61830551 61895895 61895896 62079775 61810763 61810764 61817016 61830553 61850598 61917456 62173492 62173493 62286109 62318820 62326381 61814296 61920901 61830534 61830534N
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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