MicroPort Recalls Profemur Plus Modular Neck Hip Prosthesis Components
MicroPort Orthopedics is recalling Profemur Plus modular neck hip prosthesis components due to an unexpected rate of postoperative fractures requiring revision surgery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with reported postoperative fractures requiring revision surgery, which constitutes significant injury reports under the severity rubric.
Plain-English summary
MicroPort Orthopedics, Inc. is recalling the Profemur Plus CoCr Modular Neck, Reference PHAC1254, Size Long, Orientation 8 degree VAR/VAL, 12/14 SLT Taper. This product is an orthopedic hip prosthesis component. The recall involves 10,489 units distributed worldwide, including the United States and various international locations.
The recall was initiated due to an unexpected rate of postoperative fractures that resulted in the need for revision surgery. The source text does not specify the number of patients affected or the specific dates of the incidents.
Healthcare providers and patients who have received this specific component should contact MicroPort Orthopedics, Inc. for further instructions regarding the recall and potential replacement or revision procedures.
The recalled product
- Product
- PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
- Manufacturer
- MicroPort Orthopedics, Inc.
- Hazard
- Affected units
- 10,489
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)
- All lot codes
Distribution
Distributed nationwide across the United States.
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