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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker RadioCapitellum, Capitellum

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  Class 2 Device Recall Stryker RadioCapitellum, Capitellum see related information
Date Initiated by Firm June 24, 2015
Date Posted August 20, 2015
Recall Status1 Terminated 3 on April 29, 2016
Recall Number Z-2428-2015
Recall Event ID 71676
510(K)Number K070236  
Product Classification Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
Product Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Code Information Part Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2; Part Number: 410-0003 (Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301         
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Paul Jahnke
Manufacturer Reason
for Recall
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
FDA Determined
Cause 2
Packaging change control
Action Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
Quantity in Commerce 16992 total
Distribution Worldwide 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 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 = JDB and Original Applicant = SMALL BONE INNOVATIONS, INC.