FDA-Device2015-11-18Class II
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide t
Stryker Howmedica Osteonics Corp.
Hazard
Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.
Sold states
Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.
Affected count
3,444 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5. Surgical instrument for knee prosthesis implantation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0249-2016Don't want to check this manually?
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