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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm September 29, 2015
Date Posting Updated November 09, 2015
Recall Status1 Terminated 3 on September 23, 2016
Recall Number Z-0249-2016
Recall Event ID 72381
510(K)Number K123486  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Ms. Aminah Crawford
201-831-5272
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 3,444 units
Distribution Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Stryker
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