The Recall Desk
LowFDA (Devices)·Z-2948-2020·Announced 2020-09-16

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.

What this means for you

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 CHROM
Affected units
12,348

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically: