FDAFDA · Food and drugs·Recall number Z-0131-2014
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Published November 13, 2013 · Recall initiated: October 7, 2013
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
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
- Lot
- Batch No. 13GM09505
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.