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.
What this means for you
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.
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