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U.S. Department of Health and Human Services

Class 2 Device Recall LIMA Modular Revision Hip Stem

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  Class 2 Device Recall LIMA Modular Revision Hip Stem see related information
Date Initiated by Firm January 10, 2017
Date Posted February 11, 2017
Recall Status1 Terminated 3 on March 31, 2017
Recall Number Z-1191-2017
Recall Event ID 76209
510(K)Number K092331  
Product Classification Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
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.
Code Information 1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Desiree Wells
512-832-9500
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DJO Global sent an Urgent Field Safety Notice letter dated January 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the Acknowledgement and receipt Form. Customers were instructed to contact Customer Service at 1-800-456-8696 to explore options for a replacement order.
Quantity in Commerce 13 devices
Distribution US Nationwide - US Nationwide in the states of MS, OH, RI, NY, OK, TX, CA, HI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = ENCORE MEDICAL, L.P.
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