Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head

FDA Recall Z-0686-2017 · Posted 2016-12-01

Recalling FirmMicroPort Orthopedics Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2016-06-21
Date Terminated2017-07-01
Product Quantity22 units

Reason for Recall

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Firm Action

MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or [email protected]. For questions regarding this recall call 901-867-4771.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100866PROFEMUR HIP SYSTEM MODULAR NECKSWrightmedicaltechnologyinc · 2010-04-28

Official Source

View FDA Recall →

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

↑