Z-0943-2017 Class II Terminated
FDA device recall Z-0943-2017 was initiated by MicroPort Orthopedics Inc. on November 17, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated August 18, 2018). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2017
- Initiation Date
- November 17, 2016
- Termination Date
- August 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution to Spain, China, and Italy
Code Information
Lot Number US100122