FDAFDA · Food and drugs·Recall number Z-2658-2017
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Published July 12, 2017 · Recall initiated: May 31, 2017
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
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
- Lot
- Lot # 292G1910
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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