PROFEMUR — Class II medical device recall Z-0943-2017
Terminated recall by MicroPort Orthopedics Inc., reported 2017-01-11. The recall is being initiated because all broach handles in the affected lot had the same non-conformity with
| Recall number | Z-0943-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroPort Orthopedics Inc., Arlington, TN, United States |
| Recall initiated | 2016-11-17 |
| Classified | 2017-01-03 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2018-08-18 |
| Countries outside the US | CN, ES, IT |
| Quantity | 20 units |
| Lot numbers | US100122 |
| Model numbers | PPW38078 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0943-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.