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Lower risk Medical device recall · FDA · Published August 25, 2017

Keystone Dental Stage-1 RDS Abutment Recall: Incorrect Expiration Date

Keystone Dental recalls Stage-1 RDS Indexed Abutments with incorrect expiration date (2202-06 instead of 2:2022-06). Affected units may expire prematurely. Contact for replacement.

🇺🇸 FDA recall #Z-0727-2018Medical deviceKeystone Dental ›
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Recalling firmKeystone Dental Inc154 Middlesex Tpke · Burlington, MA 01803-4403
✎ GovInfoNow plain-language explainer

What happened, in plain English

Keystone Dental is recalling Stage-1 RDS Indexed Abutments that have an incorrect expiration date label. This could lead to premature expiration of the product, potentially affecting the implant's safety and effectiveness. Read more at govinfonow.com/recall/73118-keystone-dental-stage-1-rds-abutment-recall-incorrect-expiration-date.

Source Summary by GovInfoNow · govinfonow.com/recall/73118-keystone-dental-stage-1-rds-abutment-recall-incorrect-expiration-date · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0727-2018

Cite this page

“Keystone Dental Stage-1 RDS Abutment Recall: Incorrect Expiration Date.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73118-keystone-dental-stage-1-rds-abutment-recall-incorrect-expiration-date. Based on FDA recall #Z-0727-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0727-2018%22&limit=1).

Why it’s dangerous

The abutment has a mislabeled expiration date (showing 2202-06 instead of 2022-06). This could cause the product to expire earlier than intended, potentially affecting the implant's safety and effectiveness.

Who’s affected

Dental professionals using Keystone Dental's Stage-1 RDS Indexed Abutments for dental implants are likely affected. Patients receiving these implants may be at risk if the abutment expires prematurely.

How to tell if you have this one

Check for the label showing expiration date 2202-06 instead of 2022-06. The product is identified by catalog number S2400K and lot number 34276.

  • Brand
    Keystone Dental
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Expiration Date

    Verify the expiration date on the label is 2202-06 instead of 2022-06.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationally.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Aug 25, 201712. FDA classified it Class II: Feb 27, 201823. Published in FDA’s Enforcement Report: Mar 7, 201834. FDA terminated the recall: Apr 16, 2019420172019
  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-0727-2018 (August 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0727-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 18, 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