PROFEMUR R RASP HANDLE recalled over sterility concerns

Recall date

November 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MicroPort Orthopedics Inc. recalls PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support…

Recall number

Z-0943-2017

FDA classification

Class II

Brand / firm

MicroPort Orthopedics Inc.

Sold / distributed

Worldwide Distribution to Spain, China, and Italy

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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