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Lower risk Medical device recall · FDA · Published December 21, 2017

DePuy Sigma HP Cemented Trochlear Implants Recall: Elevated Revision Rates

DePuy recalls specific Sigma HP cemented trochlear implants due to higher-than-expected revision rates observed in post-market use. Affected products include left and right narrow sizes 1-5 with catalog numbers 102403100-102404500.

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

🇺🇸 FDA recall #Z-1219-2018Medical deviceDePuy ›
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Contact the company

Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
✎ GovInfoNow plain-language explainer

DePuy is recalling specific Sigma HP cemented trochlear implants for knee replacements because they have higher-than-expected revision rates. This means some implants may need to be replaced sooner than expected, which could lead to additional surgery or complications. Read more at govinfonow.com/recall/72239-depuy-sigma-hp-cemented-trochlear-implants-recall-elevated-revision-rates.

Source Summary by GovInfoNow · govinfonow.com/recall/72239-depuy-sigma-hp-cemented-trochlear-implants-recall-elevated-revision-rates · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1219-2018

Cite this page

“DePuy Sigma HP Cemented Trochlear Implants Recall: Elevated Revision Rates.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72239-depuy-sigma-hp-cemented-trochlear-implants-recall-elevated-revision-rates. Based on FDA recall #Z-1219-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2018%22&limit=1).

The FDA announced on Dec. 21, 2017, that DePuy Orthopaedics, Inc. recalled Sigma HP Cemented Trochlear Implants due to elevated revision rates. The agency classified the recall as Class II.

How to tell if you have it

  • Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614
  • Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621
  • Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638
  • Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645
  • Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652
  • Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669
  • Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676
  • Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683
  • Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690
  • Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706

The hazard

The SIGMA HP PFJ Cemented Trochlear Implants are being recalled based on elevated revision rates observed as part of the company's post-market surveillance process. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since July 12, 2017. Other recent recalls of similar products include Howmedica SCORPIO C-DOME/PATELLA Implants Recall (July 30, 2026), Howmedica SCORPIO Patella Implants Recall (July 30, 2026), and Howmedica DURACON XL Angled Tibial Implants Recall (July 30, 2026).

How to tell if you have this one

Check if your implant has a catalog number starting with 102403100 to 102404500 or a GTIN starting with 10603295001614 to 10603295001706. The recall covers all lots of these specific implant models.

  • Brand
    DePuy
  • Product
    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Details

    Review your implant's catalog number and GTIN to confirm if it matches the recalled models listed in the notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

Alaska: named in the noticeAKMaine: 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: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: 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: named in the noticeARTennessee: 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: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Dec 21, 201712. FDA classified it Class II: Mar 27, 201823. Published in FDA’s Enforcement Report: Apr 4, 201834. FDA terminated the recall: Apr 1, 2020420172020
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything if I have this implant?

The recall does not require immediate action. Patients should check their implant details to confirm if it is affected, but no action is needed unless the implant is part of the recalled models.

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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-1219-2018 (December 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1219-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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