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Terminated

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

FDA Recall Z-2743-2015 · Posted 2015-09-28

Recalling FirmMicroPort Orthopedics, Inc.
Recall StatusTerminated
Product CodeMBL
Date Initiated2015-08-04
Date Terminated2018-08-17
Product Quantity10,489 units

Reason for Recall

Unexpected rate of postoperative fractures resulting in the need for revision surgery.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100866PROFEMUR HIP SYSTEM MODULAR NECKSWrightmedicaltechnologyinc · 2010-04-28K091423PROFEMUR HIP SYSTEM MODULAR NECKSWrightmedicaltechnologyinc · 2009-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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