MicroPort Orthopedics Inc. recalls Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalo…
Reason for recall
Due to products not having FDA Premarket authorization to be distributed within the United States.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 36MMREUSABLE3 affected lotsHTHT003600192629320130M684HTHT00361
What the firm is doing
On 12/19/2025, the firm email an "MicroPort Voluntary Recall - R25120001 HIPTURN Femoral Trial Head" communication to customers informing them that MicroPort was notified by the FDA that this device was not properly classified as a CLASS I device. MicroPort has decided not to pursue clearance of the device with a new FDA 510(k) submission and therefore has initiated field action to remove the device from the market. Customer are instructed to return the complete kits to MicroPort Orthopedics. For Questions - contact Bryan Callahan at 901-867-4594 or email address bryan.callahan@ortho.microport.com
DistributionShow detailsHide
The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1133-2026
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MicroPort Orthopedics Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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