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U.S. Department of Health and Human Services

Class 2 Device Recall Positioner/Aligner

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  Class 2 Device Recall Positioner/Aligner see related information
Date Initiated by Firm September 08, 2017
Create Date November 06, 2017
Recall Status1 Completed
Recall Number Z-0068-2018
Recall Event ID 78109
510(K)Number K141395  
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Delta Cup Beater  Positioner - Aligner, model # 9057.20.555

Used during implantation of the Delta Acetabular System
Code Information Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Frazione Villanova
San Daniele del Friuli Italy
For Additional Information Contact
800-962-2578
Manufacturer Reason
for Recall		 An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
FDA Determined
Cause 2		 Vendor change control
Action The Firm, Lima Corporate has notified the US agents of the recall and asked to check each single set with the affected product codes, identify the items and remove them from the inventory. The US distributors have also been instructed to fill out and sign a response document specifying the quantities returned. For further questions, please call (800) 962-2578.
Quantity in Commerce 20 units in (US)
Distribution Worldwide Distribution - US Distribution and to the countries of : Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Italy, New Zealand, Poland, Russia, Slovakia, Slovenia, Spain, South Africa, Switzerland, Turkey, UK and Germany
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.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = LIMACORPORATE S.P.A.
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