Z-2760-2019Class II

TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 -

Name: Z-2760-2019 TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 -
Creator: Howmedica Osteonics Corp.
Published: 2019-08-19
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2019-08-19 / Terminated / root cause: design

FDA source

Howmedica Osteonics Corp. began a recall of TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral... on 2019-08-19. FDA classified it as Class II and gives the reason as "Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2760-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Posted: 2019-09-27
Terminated: 2020-05-06
Recalling firm: Howmedica Osteonics Corp
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).
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Root cause tag: design
FDA root cause: 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 [email protected]. 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2760-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2757-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27
Z-2758-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27
Z-2759-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27
Z-2760-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-27

Product code MBH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)