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U.S. Department of Health and Human Services

Class 2 Device Recall MUTARS RS cup and LUMiC TiN

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  Class 2 Device Recall MUTARS RS cup and LUMiC TiN see related information
Date Initiated by Firm December 28, 2017
Create Date July 20, 2018
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-2517-2018
Recall Event ID 80498
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component.

Size 38/39 mm REF number 02423839
Size 42/44 mm REF number 02424244
Size 44/48 mm REF number 02424448
Size 46/52 mm REF number 02424652
Code Information Article/Batch numbers: Size 38/39 mm REF number 02423839 Batch 150201G, 1504298, 1504299, 150429C, 150429L;  Size 42/44 mm REF number 02424244 Batch 1702188, 15042AF, 15042A7, 15042A6, 15042A5;  Size 44/48 mm REF number 02424448 Batch 1702189, 1637108, 16141C1;  Size 46/52 mm REF number 02424652 Batch 1637109, 16141C2.
Recalling Firm/
Luneburger Schanze 26
Buxtehude Germany
For Additional Information Contact Mr. Dave McGurl
Manufacturer Reason
for Recall
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
FDA Determined
Cause 2
Process design
Action Implantcast sent customers an Urgent Product Safety Information / Product Recall letter on December 28, 2017. The letter recommends that physicians follow their patients by radiological exam. There is a return form for the hospital or physician to confirm receipt of the letter.
Quantity in Commerce 304, 3 in US
Distribution Distribution in Europe and US states of Texas, Rhode Island and Georgia.
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.