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Unrated Medical device recall · FDA · Published October 31, 2018

Zimmer Biomet NexGen Complete Knee Solution Femoral Augment Block Recall: Missing Screw

Zimmer Biomet recalls NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw (Item #00599003523) due to missing screw in package. Affected patients should contact manufacturer for details.

🇺🇸 FDA recall #Z-0630-2019Medical deviceZimmer Biomet ›
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Contact the company

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

What happened, in plain English

Zimmer Biomet is recalling a specific knee implant component because the package may be missing the screw. This could lead to improper installation and potential complications during surgery. Read more at govinfonow.com/recall/69538-zimmer-biomet-nexgen-complete-knee-solution-femoral-augment-block-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/69538-zimmer-biomet-nexgen-complete-knee-solution-femoral-augment-block-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0630-2019

Cite this page

“Zimmer Biomet NexGen Complete Knee Solution Femoral Augment Block Recall: Missing Screw.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69538-zimmer-biomet-nexgen-complete-knee-solution-femoral-augment-block-recall. Based on FDA recall #Z-0630-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0630-2019%22&limit=1).

Why it’s dangerous

The screw is missing from the package, which could result in the implant not being properly secured during surgery. This might cause improper alignment or instability of the knee joint after the procedure.

Who’s affected

Patients who received this specific knee implant component (NexGen Distal Femoral Augment Block) are affected. Surgeons and medical staff who used this component during procedures are at highest risk.

How to tell if you have this one

Check for the item number 00599003523 on the package. The product is a NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw. This was sold with lot number 62925336.

  • Brand
    Zimmer Biomet
  • Product
    NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Package for Screw

    Verify that the screw is included in the package. If missing, contact Zimmer Biomet for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, New Jersey, New York, Ohio, Pennsylvania, Texas, West Virginia.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Oct 31, 201812. FDA classified it Class II: Dec 18, 201823. Published in FDA’s Enforcement Report: Dec 26, 201834. FDA terminated the recall: Apr 8, 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.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall states the screw may be missing from the package, which could lead to improper installation during surgery. However, the hazard is not described as causing serious injury in normal use.

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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-0630-2019 (October 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0630-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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