FDAFDA · Food and drugs·Recall number Z-1191-2017
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Published February 22, 2017 · Recall initiated: January 10, 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
Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
- Lot
- 1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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