Skip to content
Lower risk Medical device recall · FDA · Published March 29, 2018

Zimmer Biomet: Segmental System Proximal Femoral Component Recall Due to Potential Debris

Zimmer Biomet recalls specific segmental system proximal femoral components for possible debris in the hole during machining, which may not have been fully cleaned. This affects certain surgical implants used in complex bone repair cases.

🇺🇸 FDA recall #Z-1381-2018Medical deviceZimmer Biomet ›
Take action

Contact the company

Recalling firmZimmer Biomet, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling a specific type of surgical implant for complex bone repair cases. The recall is due to a potential debris issue in the device's hole that may not have been properly cleaned during manufacturing, which could lead to complications during surgery. Read more at govinfonow.com/recall/71580-zimmer-biomet-segmental-system-proximal-femoral-component-recall-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/71580-zimmer-biomet-segmental-system-proximal-femoral-component-recall-due-to · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1381-2018

Cite this page

“Zimmer Biomet: Segmental System Proximal Femoral Component Recall Due to Potential Debris.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71580-zimmer-biomet-segmental-system-proximal-femoral-component-recall-due-to. Based on FDA recall #Z-1381-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1381-2018%22&limit=1).

The FDA announced on March 29, 2018, that Zimmer Biomet, Inc. recalled its Zimmer Segmental System Proximal Femoral Component 38mm Offset due to potential debris in the device hole. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Zimmer Biomet
  • Product: Zimmer Segmental System Proximal Femoral Component 38mm Offset
  • Model Number: 00-5850-030-38

The hazard

According to the FDA, there is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Other recent recalls of similar products include Zimmer Persona Revision Femoral Distal Augment Recall (May 11, 2026) and Biomet Intramedullary Bone Saw Blade Recalls (July 1, 2026).

How to tell if you have this one

Check if your implant has the model number 00-5850-030-38. This component is used in complex salvage cases for severe bone loss due to disease, trauma, or revision.

  • Brand
    Zimmer Biomet
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Model

    Verify if your implant has the model number 00-5850-030-38.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 38 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth 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: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: 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: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries…” 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, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Mar 29, 201812. FDA classified it Class II: Apr 16, 201823. Published in FDA’s Enforcement Report: Apr 25, 201834. FDA terminated the recall: Dec 17, 2019420182019
  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.

Similar recalls

Latest medical device recalls

Keep exploring

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-1381-2018 (March 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1381-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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