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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, AF1C11M, AF1C11MT, AF1C11X1, AF1C12, AF1C12R, AF1E01, AF1E01D, AF1E01D1, AF1E01D1R, AF1E01M, AF1E01MR, AF1E01MR1, AF1E01MX1, AF1E01MX2, AF1E01MX2R, AF1E01MX3, AF1E01R, AF1E01R1, AF1E07, AF1E08, AF1K14, AF1K14R, AF1T43, AF1W33, AF1W34, AF1W36, AF2C11, AF2C11A, AF2C11G, AF2C11R, AF2C12, AF2C12A, AF2C12A1, AF2C12R, AF2C53, AF2C53A, AF2C58, AF2C58M, AF2C58R, AF2S08, AF3L05, AF3L05P, AF3S11, AF3T02, AF3T02J, AF3V02, AF3V02J, AF3V09, AF3V09A, AF3W04, AF3W04D, AF3W29, AF3W29D, AF3W29X1, AF4C07, AF4C07M, AF4C07P, AF4C07X1, AF5A01, AF5A02, AF5A03, AF5K00, AF5S00, AF5S00T, AF5V01, AF5V01H, AF6E03, AF6E03N, AF6E03T, AF6E03TE, AF6E04, AF6E04J, AF6E04N, AF6K00, AF6K00A, AF6K00D, AF6K00L, AF6K05, AF6K05D, AF6K05H, AF6K05X, AF7A00, AF7A00L, AF7C01. AF7C01E, AF7E00, AF7H01, AF8S00, AF8V03, AF8V03A, AF8W00, AF9E00, AF9L00, AF9L00A, AF9N00, AF9T00, AF9T00E, AFZV06, AFZV18, AFZV18A, AFZV18R, AFZW21, AFZW21A, AFZW22, AFZW23, AFZW23A, AFZW23R, AFZW23R1, AFZW23R2, AFZW23W, AFZW23X1 and AFZW23X1R
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Howmedica Osteonics Corp.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, AF1C11M, AF1C11MT, AF1C11X1, AF1C12, AF1C12R, AF1E01, AF1E01D, AF1E01D1, AF1E01D1R, AF1E01M, AF1E01MR, AF1E01MR1, AF1E01MX1, AF1E01MX2, AF1E01MX2R, AF1E01MX3, AF1E01R, AF1E01R1, AF1E07, AF1E08, AF1K14, AF1K14R, AF1T43, AF1W33, AF1W34, AF1W36, AF2C11, AF2C11A, AF2C11G, AF2C11R, AF2C12, AF2C12A, AF2C12A1, AF2C12R, AF2C53, AF2C53A, AF2C58, AF2C58M, AF2C58R, AF2S08, AF3L05, AF3L05P, AF3S11, AF3T02, AF3T02J, AF3V02, AF3V02J, AF3V09, AF3V09A, AF3W04, AF3W04D, AF3W29, AF3W29D, AF3W29X1, AF4C07, AF4C07M, AF4C07P, AF4C07X1, AF5A01, AF5A02, AF5A03, AF5K00, AF5S00, AF5S00T, AF5V01, AF5V01H, AF6E03, AF6E03N, AF6E03T, AF6E03TE, AF6E04, AF6E04J, AF6E04N, AF6K00, AF6K00A, AF6K00D, AF6K00L, AF6K05, AF6K05D, AF6K05H, AF6K05X, AF7A00, AF7A00L, AF7C01. AF7C01E, AF7E00, AF7H01, AF8S00, AF8V03, AF8V03A, AF8W00, AF9E00, AF9L00, AF9L00A, AF9N00, AF9T00, AF9T00E, AFZV06, AFZV18, AFZV18A, AFZV18R, AFZW21, AFZW21A, AFZW22, AFZW23, AFZW23A, AFZW23R, AFZW23R1, AFZW23R2, AFZW23W, AFZW23X1 and AFZW23X1R
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0249-2016
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