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Class 2 Device Recall Stryker Sigmoid Notch, Radial Plate |
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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
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Product Classification |
Prosthesis, wrist, hemi-, ulnar - Product Code KXE
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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
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For Additional Information Contact |
Mr. Paul Jahnke 201-831-5826
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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.
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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
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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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510(K) Database |
510(K)s with Product Code = KXE and Original Applicant = SMALL BONE INNOVATIONS INC.
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