PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
FDA Recall Z-2588-2016 · Posted 2016-08-18
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Recalling FirmMicroPort Orthopedics Inc.
Recall StatusTerminated
Product CodeLWJ
Date Initiated2016-06-30
Date Terminated2017-01-21
Product Quantity14 units
Reason for Recall
Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
Firm Action
The firm initiated their recall by email on 06/30/2016.
Root Cause
Error in labeling
Distribution Pattern
Belgium, Italy, Spain, and Poland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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