The Recall Desk
SevereFDA (Devices)·Z-2743-2015·Announced 2015-10-07

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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.