MicroPort recalls HIPTURN Fem Head Trial 36mm (HTHT003: no FDA premarket approval for US distribution. Affected units sold in the US must stop use immediately.
Due to products not having FDA Premarket authorization to be distributed within the United States.
MicroPort is recalling its HIPTURN Fem Head Trial 36mm reusable surgical implants (model HTHT0036) because they lack FDA premarket approval for US distribution. This means the products were not legally approved to be sold in the United States, posing a regulatory risk.
The products were distributed in the US without receiving FDA premarket authorization, which is a legal requirement for medical devices. This means the devices were not tested or approved for safety and effectiveness before being sold in the United States.
US customers who purchased the MicroPort HIPTURN Fem Head Trial 36mm (model HTHT0036) implants are affected. Patients using these implants for surgery are at risk due to the lack of FDA approval.
Check for the model number HTHT0036 on the product label. The product was sold in the US with no future lots planned, so all units with this model number are affected.
The recalled product was distributed without FDA premarket approval in the US, so affected units must not be used.
The product was distributed in the US without FDA premarket authorization, which is a legal requirement for medical devices.
Check for the model number HTHT0036 on the product label. All units with this model number were sold in the US with no future lots planned.
Stop using it immediately as it was distributed without FDA premarket approval in the US.
We’ve drafted a message you can send MicroPort to request your refund or repair — edit it as you like.
Subject: Recall Z-1133-2026 — MicroPort MicroPort Hello, I own a MicroPort that is covered by recall Z-1133-2026 from MicroPort. 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.
