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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 TiNsee related information
Date Initiated by FirmDecember 28, 2017
Create DateJuly 20, 2018
Recall Status1 Terminated 3 on September 01, 2020
Recall NumberZ-2517-2018
Recall Event ID 80498
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product2M 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/
Manufacturer		 IMPLANTCAST GMBH
Luneburger Schanze 26
Buxtehude Germany
For Additional Information ContactMr. Dave McGurl
202-552-5797
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
ActionImplantcast 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 Commerce304, 3 in US
DistributionDistribution in Europe and US states of Texas, Rhode Island and Georgia.
Total Product Life CycleTPLC 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.
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