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

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.

MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to [email protected]. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.