Class II U.S. Food and Drug Administration

Brand Name: MicroPort Product Name: Hipturn FEM Head Trial 36MM recall: Due to products not having FDA Premarket authorization to be distributed

Recall published 9 months ago

Due to products not having FDA Premarket authorization to be distributed within the United States.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Due to products not having FDA Premarket authorization to be distributed within the United States.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1133-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
MicroPort Orthopedics Inc.
Product type
Medical devices
Units affected
91
Distribution
California, Colorado, Florida, Georgia, Illinois, Kansas, Maryland, Michigan, Missouri, Tennessee, Texas, Washington, Wisconsin
Made in
United States
Lot / code info
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361

Products covered by this recall

Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • HTHT0036 Software Version
  • HTHT0036

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

MicroPort Orthopedics Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: MicroPort Orthopedics Inc. — 5677 Airline Rd, Arlington, TN, 38002-9501

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was MicroPort Orthopedics Inc. medical devices recalled?

Due to products not having FDA Premarket authorization to be distributed within the United States. Due to products not having FDA Premarket authorization to be distributed within the United States.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number HTHT0036 Software Version, HTHT0036. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Which states were affected?

The notice lists California, Colorado, Florida, Georgia, Illinois, Kansas, Maryland, Michigan, Missouri, Tennessee, Texas, Washington and others.

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