Z-1191-2017 Class II Terminated
FDA device recall Z-1191-2017 was initiated by Encore Medical, Lp on January 10, 2017 and is designated Class II. 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 … The recall status is terminated (terminated March 31, 2017). Affected quantity: 13 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2017
- Initiation Date
- January 10, 2017
- Termination Date
- March 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 devices
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.
Distribution Pattern
US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
Code Information
1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A