MicroPort Orthopedics Inc.: Medical Device Recall in 2017 - (Recall #: Z-0943-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 17, 2016

Date Posted: January 11, 2017

Recall Number: Z-0943-2017

Event ID: 75888

Reason for Recall:

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.

Status: Terminated

Product Quantity: 20 units

Code Information:

Lot Number US100122

Distribution Pattern:

Worldwide Distribution to Spain, China, and Italy

Voluntary or Mandated:

Voluntary: Firm initiated