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U.S. Department of Health and Human Services

Class 2 Device Recall SMR glenosphere impactor/extractor

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  Class 2 Device Recall SMR glenosphere impactor/extractor see related information
Date Initiated by Firm April 08, 2016
Create Date May 25, 2016
Recall Status1 Terminated 3 on December 05, 2016
Recall Number Z-1711-2016
Recall Event ID 73870
510(K)Number K110598  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Code Information Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
San Daniele Del Friuli Italy
Manufacturer Reason
for Recall		 Complaints of intra-operative breakage of the glenosphere impactors/extractors.
FDA Determined
Cause 2		 Component design/selection
Action The affected firms received written notification to all distributors. The letter instructed the consignee to identify and remove all affected product in stock and return parts to Lima USA.
Quantity in Commerce 314 units
Distribution Distributed US (nationwide) and in Australia.
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 = KWS and Original Applicant = LIMACORPORATE S.P.A.
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