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
Is Profemur Plus CoCr Modular Neck recalled?
Yes. MicroPort Orthopedics recalled Profemur Plus CoCr Modular Neck on 4 Aug 2015. The recall is Class I and its status is Terminated. Recall number Z-2743-2015.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from MicroPort Orthopedics
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|---|---|---|---|---|---|
| Device | CLASS II | MicroPort Hipturn Fem Head Trial Reusable recalled | MicroPort Orthopedics | Device Malfunction | 13 states |
| Device | CLASS II | Evolution Mp Femoral Component Cs/cr Porous Size 5 Right Primary recalled | MicroPort Orthopedics | Packaging Defects | TN |
| Device | CLASS II | Evolution¿ MP Femoral CS/CR Non-Porous Non-porous recalled | MicroPort Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Evolution MP Tibial Bases, Size 2+ Left recalled | MicroPort Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Evolution MP Tibial Bases, Size 7 Left recalled by MicroPort Orthopedics | MicroPort Orthopedics | Packaging Defects | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |