Recall Z-0943-2017— MicroPort Orthopedics Inc.
Class II · Terminated
Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2016-11-17, terminated 2018-08-18. It names one FDA 510(k) clearance: K012091. 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. 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..
- Recalling firm
- MicroPort Orthopedics Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-17
- Terminated
- 2018-08-18
- Firm location
- Arlington, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.