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Lower risk Medical device recall · FDA · Published February 22, 2021

DePuy ATTUNE Fixed Bearing Knee Recall: Potential Damaged Packaging Risk

DePuy recalls specific lots of ATTUNE fixed bearing knee implants due to potential damaged packaging. These components are used in total knee replacements and may pose risks during surgical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1314-2021Medical deviceDePuy ›
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Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
✎ GovInfoNow plain-language explainer

DePuy is recalling certain lots of ATTUNE fixed bearing knee implants because of potential damaged packaging. This could affect the safety of the surgical procedure when these implants are used in total knee replacements. Read more at govinfonow.com/recall/63244-depuy-attune-fixed-bearing-knee-recall-potential-damaged-packaging-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63244-depuy-attune-fixed-bearing-knee-recall-potential-damaged-packaging-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1314-2021

Cite this page

“DePuy ATTUNE Fixed Bearing Knee Recall: Potential Damaged Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63244-depuy-attune-fixed-bearing-knee-recall-potential-damaged-packaging-risk. Based on FDA recall #Z-1314-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2021%22&limit=1).

The FDA announced on Feb. 22, 2021, that DePuy Orthopaedics is recalling ATTUNE Fixed Bearing Knee components due to potential damaged packaging. The agency issued recall number Z-1314-2021 for the Class II device.

How to tell if you have it

  • Brand: DePuy
  • Product: ATTUNE FIXED BEARING KNEE
  • Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054
  • Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061
  • Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078
  • Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078
  • Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085
  • Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092
  • Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108
  • Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108
  • Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115

The hazard

The company is removing 37 lots of ATTUNE (S+) Tibial Bases globally due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty and are designed for cemented applications.

Context

GovInfoNow's records show DePuy Orthopaedics has 23 other recalls on record since July 12, 2017. Other recent recalls of similar products include ATTUNE Knee Component Due to Incorrect Labeling (March 12, 2024), Attune Revision Limb Preservation Tibial Insert XSM 26MM Recall (Feb. 15, 2023), and ATTUNE Sizing Guide Recall (June 29, 2022). Additional recent recalls of similar products include Depuy ATTUNE Revision Hinge Knee Insert Components (May 19, 2026), Depuy ATTUNE Revision Hinge Knee Components (May 19, 2026), and Depuy ATTUNE Revision Hinge Femoral LT SZ 5 CEM (April 3, 2026).

How to tell if you have this one

Check the lot numbers: 9558300, 9555958, 9554006, 9556397, 9558618, 9557992, 9558238, 9558239, 9555613. The product codes are 150670003 through 150670009.

  • Brand
    DePuy
  • Product
    ATTUNE¿ FIXED BEARING KNEE
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.
Recall numberProduct, codes & lotsQuantity
Z-1314-2021ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.; Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061 Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078 Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078 Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085 Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092 Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108 Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108 Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115102 units total (Domestic: 6 units, Foreign: 86 units)
Z-1315-2021The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.; Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795102 units total (Domestic: 0 units, Foreign: 162 units)
Z-1316-2021The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.; Lot: 9557372, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557439, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557440, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557450, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557460, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557444, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557445, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557446, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557453, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557455, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557376, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557377, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557457, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557471, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557473, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557476, Product Code: 150680005, GTIN: 10603295492177 Lot: 9556100. Product Code: 150680006, GTIN: 10603295492184 Lot: 9556127, Product Code: 150680006, GTIN: 10603295492184 Lot: 9556128, Product Code: 150680006, GTIN: 10603295492184 Lot: 9557434, Product Code: 150680007, GTIN: 10603295492191355 units total (Domestic: 177 units, Foreign: 178 units)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the lot number and product code on the packaging to determine if it is one of the recalled lots.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 37 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Feb 22, 202112. FDA classified it Class II: Mar 29, 202123. Published in FDA’s Enforcement Report: Apr 7, 202134. FDA terminated the recall: Oct 11, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1314-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1314-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA