Recall Z-1191-2017— Encore Medical, Lp

Name: FDA recall Z-1191-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-10

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2017-01-10, terminated 2017-03-31. It names one FDA 510(k) clearance: K092331. Product: 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.. Reason: 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..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Terminated: 2017-03-31
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K092331 — DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110Encore Medical L.P.·cleared 2010-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.