FDA Device recall Z-0943-2017
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of…
- FDA Device
- Class II
- terminated
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of… by Microport Orthopedics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0943-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-17 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microport Orthopedics |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot Number US100122 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Microport Orthopedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0943-2017%22
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