Hip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot
MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a manufacturing defect. No illnesses or injuries have been reported. The missing plasma coating poses a risk to implant stability and function, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
MicroPort Orthopedics Inc. is recalling one manufacturing lot (Lot 1903727) of PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK hip replacement implants.
The recalled units are missing the plasma-spray coating in the proximal region of the stem body. This is a manufacturing defect identified in this production lot.
Approximately 8 units were distributed worldwide, with U.S. distribution in Florida, Indiana, Missouri, and California, as well as Canada.
Patients who received implants from this lot should contact their surgeon for evaluation and guidance. No illnesses or injuries related to this defect have been reported to date.
The recalled product
- Product
- PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 8
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 (4)
- Catalog Number(s): PHAPCLS7
- Lot Number(s): 1903727
- Expiration Date: 11/24/2029
- UDI/DI Number: 00192629112773
Distribution
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