Terminated

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).

FDA Recall Z-2758-2019 · Posted None

Recalling FirmHowmedica Osteonics Corp.

Recall StatusTerminated

Product CodeMBH

Date Initiated2019-08-19

Date Terminated2020-05-06

Product Quantity171 units

Reason for Recall

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

Firm 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

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics) · 2019-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.