Recall Z-2588-2016
MicroPort Orthopedics Inc. · initiated June 30, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot number 1645222
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).
FDA-determined cause: Error in labeling
Action taken
The firm initiated their recall by email on 06/30/2016.
Details
- Recall number
- Z-2588-2016
- Initiated
- June 30, 2016
- Posted by FDA
- August 18, 2016
- Terminated
- January 21, 2017
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 14 units
- Distribution
- Belgium, Italy, Spain, and Poland
- Recalling firm
- MicroPort Orthopedics Inc., Arlington, TN