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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-2760-2019
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 15MM - SIZE 2 RIGHT
Catalog # 5542-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# A3G9I A3L3E A494U A737R A7O3V A9Z9I AB34V AEU3A AEV4T AGT3G AGU9H AH73U AHE9A ALS7R AOG7L ARD3S ASS9S ASU7H ATY7Z AXZ3G AY37S BAS4A BBX7R BDV9H BEL3L BEZ3G BG34H BGL3Y BLZ4V BO49D BOA3B BOX9G BRG9O BRV7A BRY9V BSR7E BSS4B BTB3H DGKJ DGSH DIXP DKAX FYPO FYRV GFMT GJLZ GJNG GLDO GZJM GZNW GZSO GZTX GZXN GZXP HUTX HWPK HXYV IBPA IBPG IDXU IKKL IKUD IMUI ISHW IXVN IYSN IZUI JBSB JBXN JHAF JHGV JJFK JORA JUWH JZWG KDER KDZP KEOH KFXJ KGSW KJEK KJHN KKPN KLXZ KSGD KSPF KTLH KUAI KUKW KYBZ LBAM LBFD MBZM MDBV MERR MFSR MIRW MMLL SZSR TROU TRVH UEYI UHER UZIY VETP VJMC VJOS VUWS VVCY VVDW WHDY WISW WIWZ WRTS WRXX WTDT WVVP WVZC WXBU WXBV WXBW WXPH WXPI WXPJ XBEH XBEI XDBP XDBR XIJA XKIW XKIX XNAC XNBF XNCN XRBV XRBW XTAS XTAT XVHZ XVMM XVMN XVNA XXIW XXIX XYHM XYHN YBDF YBDG YCEY YCEZ YCZV YCZW YFCI YFCJ YGJM YGJN YHHU YHPT YHPU 
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 159 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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