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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Femoral Distal Augment

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  Class 2 Device Recall Triathlon Femoral Distal Augment see related information
Date Initiated by Firm August 19, 2019
Create Date September 27, 2019
Recall Status1 Terminated 3 on May 06, 2020
Recall Number Z-2758-2019
Recall Event ID 83671
510(K)Number K141056  K190991  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT
Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
Code Information All lots with an expiration date on or before 31 June 2024.  Lot# A3E7R A3H9I A7A9A A9U7R AB37T AB74U ABB7S AE49B AES9B AGAR AGAS AGB3E AGT4E AGV3G AH37L AIO4V AO74U AOD9I ARO9B ASV7B ATA9R ATY3T AU99O AUX7R AY33Z AYO4V BAA4S BAB7Y BAH3D BAI7D BBE4R BBL4Y BDZ9H BER7H BH97L BLY9D BO77U BRR9H BRT7Z BSI4X BTD9B DGFR DGPY DNUW DOFW DRFR DRPA DYEK DYRN EDHL FNYJ FOGV FVVR FYST FYTP GFPG GJMG GJNM GYOD GYVG GZNA GZRT GZWG GZWS HHXY HHZF HHZZ HIBF HUPS HVBW HYHG HYJB IBTS IBTW IEVY ILAX ILBL INJO INNB INNE IUWT IVAB IYLR JBYI JFGV JFNZ JHDR JIKH JILH JNIX JVEZ JZSI KFYW KHHJ KHNX KHSO KMEX KSPV KVRZ KVVS KWPV KYND KZYB MEDM MFZX MGLY MLBP MMFV NEBU S3HS SOBP SPO4 SR4E TGGA TIYY TPPH TPTI UHIP USLI UT3I UZDD V4AH VA3Y VBGT VGGG VJHG VJYO VPBW VPYA VT43 VUWT VVJG VW3E WGRG WO4G WOYL WPJT WRXC WRYC WSDE WVWI WVWJ WXAV WXAW XAVX XAVY XDYL XDYM XGDX XGDY XIJC XKSY XKSZ XOCL XOCM XTJY XTJZ XVIO XVIP XWVK XWVM XYGP XYGR YBCC YBCD YESI YFJX YFJY YG3H YGSJ YGSK
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Ms. Loriann Russo,
201-831-5272
Manufacturer Reason
for Recall		 Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
FDA Determined
Cause 2		 Device Design
Action 1. Inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-877-551-7148 or email to strykerortho4636@stericycle.com. 5. Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2144473
Quantity in Commerce 171 units
Distribution Worldwide distribution - US Nationwide distribution including the states of AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Honk Kong, India, Ireland, Iran, Italy, Israel, Japan, Kazakhstan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and UK.
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 = MBH and Original Applicant = Howmedica Osteonics Corp. (aka Stryker Orthopaedics)
510(K)s with Product Code = MBH and Original Applicant = STRYKER ORTHOPAEDICS
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