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.
FDA Recall Z-0249-2016 · Posted 2015-11-09
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2015-09-29
Date Terminated2016-09-23
Product Quantity3,444 units
Reason for Recall
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.
Firm Action
Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826.
For questions regarding this recall call 201-831-5272.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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