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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Femoral Distal Augment Left

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  Class 2 Device Recall Triathlon Femoral Distal Augment Left see related information
Date Initiated by Firm March 25, 2013
Date Posted May 23, 2013
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-1370-2013
Recall Event ID 64941
510(K)Number K070095  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package

Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA

Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881
Meyzieu, Cedex, France

This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
Code Information Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Ms. Christie Samsa
201-831-5970
Manufacturer Reason
for Recall		 Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
FDA Determined
Cause 2		 Software design
Action The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.
Quantity in Commerce 11 units
Distribution Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
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 = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
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