FDA-Device2017-02-22Class II
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.
Encore Medical, Lp
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.
Sold states
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
Affected count
13 devices
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1191-2017Don't want to check this manually?
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