PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 22, 2017 Initiated: January 10, 2017 #Z-1191-2017

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.

Details

Recalling Firm
Encore Medical, Lp
Units Affected
13 devices
Distribution
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
Location
Austin, TX

Frequently Asked Questions

What product 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.. Recalled by Encore Medical, Lp. Units affected: 13 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1191-2017.

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