Food, drugs, devices › MicroPort Orthopedics Inc.
Device recall: PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip
MicroPort Orthopedics Inc. (Arlington, TN) initiated this device recall on 31 Jul 2020; FDA lists 2 product records under event 86153, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 16 Apr 2024. Initiation: voluntary: firm initiated. MicroPort Orthopedics Inc. has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MicroPort Orthopedics Inc., Arlington, TN.
Reason for recall
"MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there…"
Distribution
"worldwide, except China and Japan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2941-2020 | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component. | 123,284 units | Class I | Terminated | 30 Sep 2020 |
| Z-2942-2020 | PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component | 556 units | Class I | Terminated | 30 Sep 2020 |
Context
Other enforcement events for MicroPort Orthopedics Inc.
All 15 events for MicroPort Orthopedics Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there…"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "worldwide, except China and Japan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.