PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
This recall has been terminated (originally issued September 28, 2015).
- Company
- Microport Orthopedics Inc.
- Recall Initiated
- August 4, 2015
- Posted
- September 28, 2015
- Terminated
- August 17, 2018
- Recall Number
- Z-2743-2015
- Quantity
- 10,489 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
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 / Code Info
All lot codes
Root Cause
Device Design
Action Taken
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.