Reusable hip trial components recalled over missing FDA premarket authorization
MicroPort Orthopedics is recalling 91 units of the HIPTURN 36mm reusable femoral head trial because the product does not have FDA premarket authorization for US distribution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a missing premarket authorization rather than a device defect, with no stated consequence or reported harm.
Plain-English summary
The MicroPort HIPTURN FEM HEAD TRIAL 36MM REUSABLE, model/catalog number HTHT0036, is being recalled by MicroPort Orthopedics Inc.
The reason given in the enforcement record is that the products do not have FDA premarket authorization to be distributed within the United States.
The record lists 91 units under part number HTHT0036, all lots, with primary DI number 00192629320130, and states that no future lots are planned. The record states 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, and also to other countries listed in the record. The FDA has classified the action as Class II.
The record cites a regulatory authorization shortfall rather than a device defect, and reports no injuries. Facilities should quarantine affected stock and follow MicroPort's instructions.
The recalled product
- Product
- 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
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Part Number HTHT0036
- all lots
Distribution
Related recalls
Same manufacturer · MicroPort Orthopedics Inc.
See all →- ModerateFemoral Knee Prosthesis Components May Have Incorrect Packaging
FDA (Devices) · 2024-12-25
- HighMicroPort Knee Implant Recall: Wrong Size Component in Packaging
FDA (Devices) · 2024-07-10
- HighMicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging
FDA (Devices) · 2023-02-22
- HighEVOLUTION MP Tibial Base knee component recalled for wrong product in packaging
FDA (Devices) · 2023-02-22
- HighHip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot
FDA (Devices) · 2022-06-08
Similar recalls
- HighDePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery
FDA (Devices) · 2014-12-24
- ModerateMicroPort Profemur Modular Neck Recalled for Labeling Error
FDA (Devices) · 2016-08-24
- SevereMicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports
FDA (Devices) · 2020-09-30
- SevereMicroPort Recalls Profemur Plus Modular Neck Hip Prosthesis Components
FDA (Devices) · 2015-10-07
- SevereZimmer Recalls Provisional Femoral Heads Due to Fit Issues
FDA (Devices) · 2012-10-10
- SevereZimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues
FDA (Devices) · 2012-10-10