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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon PKR Insert X3 1

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  Class 2 Device Recall Triathlon PKR Insert X3 1 see related information
Date Initiated by Firm November 25, 2008
Date Posted January 12, 2009
Recall Status1 Terminated 3 on August 30, 2010
Recall Number Z-0869-2009
Recall Event ID 50535
510(K)Number K071881  
Product Classification Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis - Product Code HRY
Product Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE

Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE

Intended Use:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or
not involving, previous use of a unicompartmental knee prosthesis
- As an alternative to tibial osteotomy in patients with unicompartmental
osteoarthritis, where bone stock is of poor quality or inadequate for other
reconstructive techniques as indicted by deficiencies of the femoral
condyle/tibia plateau.

These components are intended for implantation with bone cement.

Stryker Orthopaedics;
Howmedica Osteonics Copr.
325 Corporate Drive
Mahwah, NJ 07430
Code Information 8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE. 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Karen Ariemma, RAC
201-831-5718
Manufacturer Reason
for Recall		 Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.
FDA Determined
Cause 2		 Labeling mix-ups
Action Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.
Quantity in Commerce 8 mm - 1 unit; 12 mm - 8 units.
Distribution Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
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 = HRY and Original Applicant = HOWMEDICA OSTEONICS CORP
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