Home / Recalls / Medical Devices
MicroPort Orthopedics Inc. recalls PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support
Recalled January 11, 2017 · FDA recall Z-0943-2017 · MicroPort Orthopedics
Hazard
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. · FDA Class II
Units
20 units
Sold at
Worldwide Distribution to Spain, China, and Italy
Description
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.
Product
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
Manufacturer(s)
MicroPort Orthopedics Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →