Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 30, 2020
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
MicroPort Orthopedics Inc. recalled PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PH… - a critical-severity action.
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PH… was recalled by MicroPort Orthopedics Inc. in September 30, 2020. Reason: MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titani…. Check the official notice for the remedy. Verify recall #Z-2941-2020 with the FDA Devices before acting.
The recall
MicroPort Orthopedics Inc. issued this critical-severity FDA Devices recall-MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titani….
- Critical
- severity level
- 123K units
- affected scope
- Class I
- classification
- September 30, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2941-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2941-2020) was formally reported on September 30, 2020, with the manufacturer initiating the action on July 31, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. MicroPort Orthopedics Inc. is listed as the recalling firm, operating out of Arlington, TN. Federal records list the affected scope as 123,284 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 Titan… Distribution data in the federal record shows the product reached: worldwide, except China and Japan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
123,284 units
Related Recalls
6
3 from same agency
Product description
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
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 were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2941-2020 |
| Date reported | September 30, 2020 |
| Date initiated | July 31, 2020 |
| Recalling firm | MicroPort Orthopedics Inc. |
| Firm location | Arlington, TN |
| Affected scope | 123,284 units |
| Distribution | worldwide, except China and Japan |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2941-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.. Recalled by MicroPort Orthopedics Inc.. Units affected: 123,284 units.
Why was this product recalled? ▼
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 were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2020. Severity: Critical. Recall number: Z-2941-2020.
Where was the recalled product distributed? ▼
Distribution: worldwide, except China and Japan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2941-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 30, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.