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

Implant Direct Swish Duo-Grip Healing Collar Recall: Wrong Component Size Risk

Implant Direct recalls Swish Duo-Grip Healing Collar (part 9048-13H) due to incorrect component size in some packages. This may cause improper fit during dental implant procedures.

🇺🇸 FDA recall #Z-0007-2018Medical deviceImplant Direct ›
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Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
✎ GovInfoNow plain-language explainer

What happened, in plain English

Implant Direct is recalling Swish Duo-Grip Healing Coll: 3mm length, 4.8mm platform dental implants. The recall is because some packages contain a smaller 3.7mm component instead of the required 4.8mm part, which could lead to improper fit during dental implant procedures. Read more at govinfonow.com/recall/73380-implant-direct-swish-duo-grip-healing-collar-recall-wrong-component.

Source Summary by GovInfoNow · govinfonow.com/recall/73380-implant-direct-swish-duo-grip-healing-collar-recall-wrong-component · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0007-2018

Cite this page

“Implant Direct Swish Duo-Grip Healing Collar Recall: Wrong Component Size Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73380-implant-direct-swish-duo-grip-healing-collar-recall-wrong-component. Based on FDA recall #Z-0007-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0007-2018%22&limit=1).

Why it’s dangerous

The Swish Duo-Grip Healing Collar is designed to be 4.8mm in platform size for dental implants. However, some packages contain a 3.7mm component instead of the required 4.8mm part. This mismatch could lead to improper fit during implant procedures, potentially causing complications.

Who’s affected

Dental patients who have been prescribed this specific healing collar for dental implants. Patients with the product code 9048-13H and lot number 81080 are most at risk.

How to tell if you have this one

Check for product code 9048-13H and lot number 81080 on the packaging. The Swish Duo-Grip Healing Collar is a sterile dental implant component that requires a prescription.

  • Brand
    Implant Direct
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product code and lot number on the packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide; 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: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: 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: “Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, New Jersey, New York, Pennsylvania, Texas, Utah.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

1. Firm started the recall: Jul 21, 201712. FDA classified it Class II: Oct 3, 201723. Published in FDA’s Enforcement Report: Oct 11, 201734. FDA terminated the recall: Apr 1, 2021420172021
  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-0007-2018 (July 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0007-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 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