FDA-Device2017-01-11Class II
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
MicroPort Orthopedics Inc.
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.
Sold states
Worldwide Distribution to Spain, China, and Italy
Affected count
20 units
Manufactured in
5677 Airline Rd, N/A, Arlington, TN, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2017Don't want to check this manually?
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