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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy

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  Class 2 Device Recall DePuy see related information
Date Initiated by Firm April 07, 2022
Create Date May 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1072-2022
Recall Event ID 89972
510(K)Number K183618  
Product Classification Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
Product Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
Code Information All serial numbers. Material GTIN Product 03.405.000S 10886982300829 Radial Head Replacement Instr Kit; 09.405.250S 10886982300614 Rad Head w/Head 22 shaft 5.5 HH10 +0; 09.405.253S 10886982300621 Rad Head w/Head 22 shaft 5.5 HH10 +3; 09.405.256S 10886982300638 Rad Head w/Head 22 shaft 5.5 HH10 +6; 09.405.260S 10886982300645 Rad Head w/Head 22 shaft 6.5 HH10 +0; 09.405.263S 10886982300652 Rad Head w/Head 22 shaft 6.5 HH10 +3; 09.405.266S 10886982300669 Rad Head w/Head 22 shaft 6.5 HH10 +6; 09.405.270S 10886982300676 Rad Head w/Head 22 shaft 7.5 HH10 +0; 09.405.273S 10886982300683 Rad Head w/Head 22 shaft 7.5 HH10 +3; 09.405.276S 10886982300690 Rad Head w/Head 22 shaft 7.5 HH10 +6; 09.405.280S 10886982300706 Rad Head w/Head 22 shaft 8.5 HH10 +0; 09.405.283S 10886982300713 Rad Head w/Head 22 shaft 8.5 HH10 +3; 09.405.286S 10886982300720 Rad Head w/Head 22 shaft 8.5 HH10 +6; 09.405.560S 10886982300737 Rad Head w/Head 25 shaft 6.5 HH11 +0; 09.405.563S 10886982300744 Rad Head w/Head 25 shaft 6.5 HH11 +3; 09.405.566S 10886982300751 Rad Head w/Head 25 shaft 6.5 HH11 +6; 09.405.570S 10886982300768 Rad Head w/Head 25 shaft 7.5 HH11 +0; 09.405.573S 10886982300775 Rad Head w/Head 25 shaft 7.5 HH11 +3; 09.405.576S 10886982300782 Rad Head w/Head 25 shaft 7.5 HH11 +6; 09.405.580S 10886982300799 Rad Head w/Head 25 shaft 8.5 HH11 +0; 09.405.583S 10886982300805 Rad Head w/Head 25 shaft 8.5 HH11 +3; 09.405.586S 10886982300812 Rad Head w/Head 25 shaft 8.5 HH11 +6; 09.405.950S 10886982300522 Rad Head w/Head 19 shaft 5.5 HH9 +0; 09.405.953S 10886982300539 Rad Head w/Head 19 shaft 5.5 HH9 +3; 09.405.956S 10886982300546 Rad Head w/Head 19 shaft 5.5 HH9 +6; 09.405.960S 10886982300553 Rad Head w/Head 19 shaft 6.5 HH9 +0; 09.405.963S 10886982300560 Rad Head w/Head 19 shaft 6.5 HH9 +3; 09.405.966S 10886982300577 Rad Head w/Head 19 shaft 6.5 HH9 +6; 09.405.970S 10886982300584 Rad Head w/Head 19 shaft 7.5 HH9 +0; 09.405.973S 10886982300591 Rad Head w/Head 19 shaft 7.5 HH9 +3; 09.405.976S 10886982300607 Rad Head w/Head 19 shaft 7.5 HH9 +6.
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall		 DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
FDA Determined
Cause 2		 Labeling Change Control
Action DePuy Synthesis issued Urgent: MEDICAL DEVICE CORRECTION (Notification) on 4/14/22. Letter states reason for recall, health risk and action to take: " Download and review the updated version of the e-IFU from the following website: https://www.e-ifu.com/search-document-metadata/radial%20head%20replacement%20system Forward this notice to all attending surgeons in your facility using this device. " Please complete, sign, and return the Business Reply Form within three (3) business days email to OneMD-Field-Actions@its.jnj.com (Please reference FA 2097468 in the subject line). Note: Product is NOT being removed from the field and does not need to be returned.
Distribution US Nationwide 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 = KWI and Original Applicant = Ignite Orthopedics, Inc.
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