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Use caution Medical device recall · FDA · Published June 23, 2017

Exactech Truliant Tibial Trial Handle Recall: Pin May Disassociate

Exactech recalls Trul:iant Tibial Trial Handle (Catalog 02-029-29-1000) due to risk of pin disassociation during surgery. Affected surgeons should contact Exactech for details.

🇺🇸 FDA recall #Z-3018-2017Medical deviceExactech ›
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Contact the company

Recalling firmExactech, Inc.2320 NW 66th Ct · Gainesville, FL 32653-1630
✎ GovInfoNow plain-language explainer

What happened, in plain English

Exactech recalls the Truliant Tibial Trial Handle used in knee surgery because its pin may detach from the main body during use. This could lead to complications during the implantation process if not addressed. Read more at govinfonow.com/recall/73615-exactech-truliant-tibial-trial-handle-recall-pin-may-disassociate.

Source Summary by GovInfoNow · govinfonow.com/recall/73615-exactech-truliant-tibial-trial-handle-recall-pin-may-disassociate · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3018-2017

Cite this page

“Exactech Truliant Tibial Trial Handle Recall: Pin May Disassociate.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73615-exactech-truliant-tibial-trial-handle-recall-pin-may-disassociate. Based on FDA recall #Z-3018-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3018-2017%22&limit=1).

Why it’s dangerous

The pin in the handle may become detached from the main body during surgery. This could cause the handle to become unstable or malfunction while implanting knee components, potentially leading to surgical complications.

Who’s affected

Surgeons who use the Truliant Tibial Trial Handle for knee replacements are most at risk. The recall affects specific models sold with Lot Number 83843-001.

How to tell if you have this one

Check for the Truliant Tibial Trial Handle with Catalog Number 02-029-29-1000 and Lot Number 83843-001. This product is used by surgeons during knee replacement procedures.

  • Brand
    Exactech
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Exactech

    Surgeons should contact Exactech directly to confirm if their specific model is affected and receive instructions.

Where it went and when

Where it was distributed

Distributed in 11 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

1. Firm started the recall: Jun 23, 201712. FDA classified it Class II: Aug 11, 201723. Published in FDA’s Enforcement Report: Aug 23, 201734. FDA terminated the recall: Nov 30, 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

Is this product safe to use?

The recall indicates a potential risk of pin disassociation during surgery, so it is not recommended for use until the manufacturer provides a solution.

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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-3018-2017 (June 23, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3018-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 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