MicroPort Orthopedics Recalls Profemur R Rasp Handles Due to Machining Issues
MicroPort Orthopedics is recalling 20 units of Profemur R Rasp Handles because machining issues may prevent them from properly mating with broaches.
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: The recall is classified as FDA Class II. The hazard is a functional defect (machining issue) that prevents proper mating, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 20 units of the Profemur(R) R Rasp Handle, reference number PPW38078. These non-sterile instruments are used to support the implantation of orthopedic implants by preparing the femoral canal for stem components.
The recall was initiated because all broach handles in the affected lot, identified by Lot Number US100122, have a non-conformity with the connection feature. The source text states that the handles may have machining issues that do not allow the handle to properly mate with an associated broach.
The affected units were distributed worldwide to Spain, China, and Italy. The source text does not specify specific end-users or hospitals, nor does it report any injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
- Manufacturer
- MicroPort Orthopedics Inc.
- Hazard
- Affected units
- 20
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 (1)
- Lot Number US100122
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · MicroPort Orthopedics Inc.
See all →- ModerateReusable hip trial components recalled over missing FDA premarket authorization
FDA (Devices) · 2026-01-28
- 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
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- ModerateMicroPort Profemur Modular Neck Recalled for Labeling Error
FDA (Devices) · 2016-08-24
- HighStryker Recalls Exeter Rasp Handle Due to Malfunctioning
FDA (Devices) · 2016-08-17
- HighMedacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk
FDA (Devices) · 2012-11-14
- SevereMicroPort Recalls Profemur Plus Modular Neck Hip Prosthesis Components
FDA (Devices) · 2015-10-07
- SevereMicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports
FDA (Devices) · 2020-09-30
- HighStryker Accolade Offset Rasp Handle Recalled for Potential Fracture
FDA (Devices) · 2012-06-27