Device 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
Z-0943-2017
Product summary
- Event
- Event 75888
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0943-2017
Official wording
Reason: 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.
Code information: Lot Number US100122
Distribution pattern: Worldwide Distribution to Spain, China, and Italy
Derived failure modes
-
Unknown
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.