Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PROFEMUR(R) R RASP HANDLE Recalled by MicroPort Orthopedics Inc. Due to The recall is being initiated because all broach...

Date: November 17, 2016
Company: MicroPort Orthopedics Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MicroPort Orthopedics Inc. directly.

Affected Products

PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This

Quantity: 20 units

Why Was This Recalled?

The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.

Where Was This Sold?

Worldwide Distribution to Spain, China, and Italy

About MicroPort Orthopedics Inc.

MicroPort Orthopedics Inc. has 30 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report