CLASS II Device recall · Reported 11 Jan 2017 · FDA Enforcement Report
Profemur(r) R Rasp Handle recalled by MicroPort Orthopedics
MicroPort Orthopedics is recalling Profemur(r) R Rasp Handle. The recall was initiated on 17 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0943-2017
- FDA event ID
- 75888
- Recalling firm
- MicroPort Orthopedics, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2016
- FDA classified
- 3 Jan 2017
- Reported
- 11 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 17 Nov 2016 | Recall initiated by company | |
| 3 Jan 2017 | Classified by FDA | +47 days |
| 11 Jan 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution to Spain, China, and Italy
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Number US100122
Where was it sold?
Worldwide Distribution to Spain, China, and Italy
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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