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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon X3

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 Class 2 Recall
Triathlon X3
see related information
Date Posted September 25, 2007
Recall Status1 Terminated on December 05, 2007
Recall Number Z-1231-2007
Recall Event ID 38624
Premarket Notification
510(K) Number
K070095 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
Code Information Product numbers: 5537-G-109, 5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125, 5537-G-128, 5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216, 5537-G-219, 5537-G-222, 5537-G-225, 5537-G-228, 5537-G-231, 5537-G-309, 5537-G-311, 5537-G-313, 5537-G-316, 5537-G-319, 5537-G-322, 5537-G-325, 5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411, 5537-G-413, 5537-G-416, 5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431, 5537-G-509, 5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525, 5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616, 5537-G-619, 5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709, 5537-G-711, 5537-G-713, 5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725, 5537-G-728, 5537-G-731, 5537-G-809, 5537-G-811, 5537-G-813, 5537-G-816, 5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828, 5537-G-831. All lot codes
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall
Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.
Action Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007.
Quantity in Commerce 14
Distribution Product distributed to 5 hospitals in GA, OH, MN, TX.
Total Product Life Cycle TPLC Device Report

 
1 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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