FDA Medical Device Recalls (openFDA)
MicroPort Orthopedics Inc.: 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.
- Recall number
- Z-2588-2016
- Recalling firm
- MicroPort Orthopedics Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-06-30
- Posted
- 2016-08-18
- Terminated
- 2017-01-21
- Reason
- Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
- Root cause
- Error in labeling
- Action
- The firm initiated their recall by email on 06/30/2016.
- Quantity
- 14 units
- Distribution
- Belgium, Italy, Spain, and Poland
- Lot, serial or model codes
- Lot number 1645222
- 510(k) numbers
- ["K003016"]
- PMA numbers
- not on file
- Product code
- LWJ
- Firm FEI
- 3010536692
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28