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.
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.
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.
The device was shipped with stainless steel implants instead of titanium as labeled. Titanium is preferred for its biocompatibility and strength in medical implants, while stainless steel may cause adverse reactions or failure during healing.
Patients who received the WishFIX Growth Control Plating System with model number TEFCS28-080US are affected. Those who have undergone orthopedic surgery using this model are most at risk.
Check for model number TEFCS28- 080US on the packaging or device label. The lot number 28042 is also associated with this specific recall batch.
Look for the model number TEFCS28-080US and lot number 28042 on the device or packaging.
The products were incorrectly packed with stainless steel implants instead of titanium as the packaging and part number indicated.
Check the device label for model number TEFCS28-080US and lot number 28042. If you have this model, contact Wishbone Medical for further instructions.
The recall is due to incorrect implant material, but the risk is low as the device is not in use until surgery. Serious injury is not indicated in the recall notice.
We’ve drafted a message you can send Wishbone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1808-2024 — Wishbone Medical Wishbone Medical Hello, I own a Wishbone Medical that is covered by recall Z-1808-2024 from Wishbone Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.