Encore Medical, Lp: Medical Device Recall in 2017 - (Recall #: Z-1191-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 10, 2017

Date Posted: February 22, 2017

Recall Number: Z-1191-2017

Event ID: 76209

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.

Status: Terminated

Product Quantity: 13 devices

Code Information:

1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated