FDA Medical Device Recalls (openFDA)
MicroPort Orthopedics, Inc.: PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
- Recall number
- Z-2743-2015
- Recalling firm
- MicroPort Orthopedics, Inc.
- Product
- PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
- Status
- Terminated
- Initiated
- 2015-08-04
- Posted
- 2015-09-28
- Terminated
- 2018-08-17
- Reason
- Unexpected rate of postoperative fractures resulting in the need for revision surgery.
- Root cause
- Device Design
- Action
- Micro Port Orthopedics sent a Voluntary Device Product Recall letter dated August 7, 2015, via Fed Ex to all affected customers. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to locate and return effected product immediately. Customers with questions were instructed to call 1-866-872-0211. Customers were also asked to return the enclosed form immediately even if they do not have any affected product to return.
- Quantity
- 10,489 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to AT, BE, CA, CN, CZ, DE, ES, FI, FR, GB, IT, KR, LT, LV, NL, NO, PE, PL, PT, RU, and ST.
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- ["K091423","K100866"]
- PMA numbers
- not on file
- Product code
- MBL
- 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