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U.S. Department of Health and Human Services

Class 2 Device Recall Trial Adaptor Head

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  Class 2 Device Recall Trial Adaptor Head see related information
Date Initiated by Firm August 14, 2015
Date Posted September 02, 2015
Recall Status1 Terminated 3 on February 26, 2016
Recall Number Z-2540-2015
Recall Event ID 71972
510(K)Number K100858  
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
Product SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
Code Information Lot Numbers: 14AA146 and 14AA153
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
San Daniele Del Friuli Italy
Manufacturer Reason
for Recall		 The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form.
Quantity in Commerce 93 units
Distribution US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to 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 = HSD and Original Applicant = LIMA-LTO S.P.A.
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