—#83571

Product

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; Non Sterile Stryker Orthopaedics 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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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.

Why it was recalled

Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2007-02-12
Posted by FDA: 2009-08-26
Terminated: 2009-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.