||August 26, 2009
||Terminated on October 15, 2009
|Recall Event ID
orthopedic manual surgical instrument -
||Triathlon AR 4:1 Cutting Blocks - Size 1-8;
Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708;
Triathlon MIS Instruments;
325 Corporate Drive
Mahwah, NJ 07430
The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
||Catalog no. 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, 7541-0-708.
All lot codes.
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
|For Additional Information Contact
|Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.
||Important Product Correction letters were sent to all branches/agencies on February 12, 2008 by Federal Express. The letter asked consignees to examine their inventory and hospital locations to identify the affected product. Customers were asked to perform a functional inspection by assembling the Triathlon Impactor/Extractor Handle to all of their MIS Cutting Blocks. If the cutting block does not assemble, customers are to list the affected lot codes on the Attached Product Accountability Form and fax a copy to (201) 831-6069. The letter states that product should not be returned until further instructions are received. Questions should be directed to (201) 831-5825.
|Quantity in Commerce
||690 total units - both varieties
|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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.