MicroPort Recalls PROFEMUR Modular Necks for Package Insert Update
MicroPort Orthopedics is voluntarily recalling PROFEMUR Titanium and Cobalt Chrome modular necks to replace older package inserts with the most recent revision.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (package insert update) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks. The recall is initiated to replace the PROFEMUR Hip System Package Insert with the most recent revision, identified as 150803-8.
The affected products are modular necks used in total hip arthroplasty for skeletally mature patients. The recall covers specific item numbers including PHAC1202, PHAC1204, and various other short, long, and x-long neck configurations in both cobalt chrome and titanium materials.
This action is a documentation update to ensure that the most current instructions for use are available for the devices. No specific injuries, illnesses, or deaths are reported in the source text.
The recalled product
- Product
- PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT…
- Manufacturer
- MicroPort Orthopedics Inc.
- Hazard
- Affected units
- 12,348
Distribution
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