| Class 2 Device Recall Trial Adaptor Head | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = HSD
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