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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Sigmoid Notch, Radial Plate

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  Class 2 Device Recall Stryker Sigmoid Notch, Radial Plate 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-2430-2015
Recall Event ID 71676
510(K)Number K061146  
Product Classification Prosthesis, wrist, hemi-, ulnar - Product Code KXE
Product Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
Code Information Part Number: 390-0305 (Sigmoid Notch Radial Stem, Small) - Lot #'s 18362, 22834401 and 23852901;  Part Number: 390-0307 (Sigmoid Notch Radial Stem, Large) - Lot #'s 18728, 18815, 18816, 18817, 23834501 and 23853001
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Paul Jahnke
201-831-5826
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.

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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