Recall Z-2743-2015 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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.
| Date | Sep 28, 2015 (initiated Aug 4, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |