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U.S. Department of Health and Human Services

Class 2 Device Recall TaperFit Stem

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  Class 2 Device Recall TaperFit Stem see related information
Date Initiated by Firm July 12, 2022
Create Date August 31, 2022
Recall Status1 Open3, Classified
Recall Number Z-1667-2022
Recall Event ID 90662
510(K)Number K142761  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Code Information Model #588.3800, Lot #494754; UDI 05055343871065
Recalling Firm/
Manufacturer		 Corin Ltd
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information Contact Mr. Dardan Uka
441285659866
Manufacturer Reason
for Recall		 Some of the devices did not pass fatigue testing.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued the recall letter dated 7/8/2022 via email to the consignee on 7/12/2022. The recall letter described the potential issue and listed the affected product. The potential risk was reported and the actions to be carried out by the customer, which included return of the product from the field and completion of the acknowledgement form to be returned via email to confirm receipt of the letter.
Quantity in Commerce 1
Distribution Distribution was made to NJ. There was no military/government distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = CORIN USA
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