Encore Medical, Lp recalls LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of…

Recall date

January 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1191-2017

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.