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Lower risk Medical device recall · FDA · Published April 5, 2024

Wishbone Medical WishFIX Growth Control Plating System Recall: Incorrect Implant Material

Wishbone Medical recalls WishFIX Growth Control Plating System (Model TEFCS28-080US) due to incorrect implant material in packaging. Affected units may have stainless steel instead of titanium.

🇺🇸 FDA recall #Z-1808-2024Medical deviceWishbone Medical ›
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Recalling firmWishbone Medical, Inc.100 Capital Dr · Warsaw, IN 46582-6704
✎ GovInfoNow plain-language explainer

Wishbone Medical is recalling a specific orthopedic device model because it was incorrectly packed with stainless steel implants instead of titanium. This mismatch could lead to complications during surgery or healing. Read more at govinfonow.com/recall/55621-wishbone-medical-wishfix-growth-control-plating-system-recall-incorrect-implant.

Source Summary by GovInfoNow · govinfonow.com/recall/55621-wishbone-medical-wishfix-growth-control-plating-system-recall-incorrect-implant · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1808-2024

Cite this page

“Wishbone Medical WishFIX Growth Control Plating System Recall: Incorrect Implant Material.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55621-wishbone-medical-wishfix-growth-control-plating-system-recall-incorrect-implant. Based on FDA recall #Z-1808-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1808-2024%22&limit=1).

Wishbone Medical, Inc. voluntarily recalled its WishFIX Growth Control Plating System on April 5, 2024, according to the FDA. The orthopedic device was distributed to Florida, New Jersey and Connecticut because it was incorrectly packed with a stainless-steel implant instead of titanium.

How to tell if you have it

  • Brand: Wishbone Medical
  • Product: WishFIX Growth Control Plating System
  • Model Number: TEFCS28-080US
  • Model Number: TEFCS28-08-US
  • UDI/DI: B562TEFCS2808US0
  • Lot Number: 28042
  • Quantity: 60 units

The hazard

The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated, according to the FDA.

Context

GovInfoNow's records show Wishbone Medical, Inc. has two other recalls on record since April 30, 2021. On Jan. 4, 2023, the firm recalled Smart Correction Struts due to an adjustment delay risk. Other recent recalls of similar products include Straumann Custom Abutment AS Ti Recall (March 17, 2026), Straumann GM Helix Dental Implant Recall (July 13, 2026) and Straumann Custom Abutment Ti Recall (March 17, 2026).

How to tell if you have this one

Check for model number TEFCS28- 080US on the packaging or device label. The lot number 28042 is also associated with this specific recall batch.

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

What to do — step by step

  1. Check Device Label

    Look for the model number TEFCS28-080US and lot number 28042 on the device or packaging.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “US distribution to Florida, New Jersey and Connecticut.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Connecticut, Florida, New Jersey.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Apr 5, 202412. FDA classified it Class II: May 10, 202423. Published in FDA’s Enforcement Report: May 22, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1808-2024 (April 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1808-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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