CLASS I Device recall · Reported 7 Oct 2015 · FDA Enforcement Report
Profemur Plus CoCr Modular Neck recalled by MicroPort Orthopedics
MicroPort Orthopedics is recalling Profemur Plus CoCr Modular Neck, distributed nationwide in the US. The recall was initiated on 4 Aug 2015 and the FDA has classified it as Class I.
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-2743-2015
- FDA event ID
- 71925
- Recalling firm
- MicroPort Orthopedics, Arlington, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Aug 2015
- FDA classified
- 28 Sep 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 4 Aug 2015 | Recall initiated by company | |
| 28 Sep 2015 | Classified by FDA | +55 days |
| 7 Oct 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Product as listed by the FDA
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
Where it was distributed
Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
Questions about this recall
Why was it recalled?
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Which lots are affected?
All lot codes
Where was it sold?
Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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