RecallDepth

PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.

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

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.

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