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Recall Observatory FDA recall evidence

Device 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.

Z-1191-2017

January 10, 2017

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 76209
Status
Terminated
Classification
Class II
Quantity
13 devices
Official record key
device-enforcement:Z-1191-2017

Official wording

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.