Z-0686-2017Class III

Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF...

Name: Z-0686-2017 Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF...
Creator: MicroPort Orthopedics Inc.
Published: 2016-06-21
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2016-06-21 / Terminated / root cause: design

FDA source

MicroPort Orthopedics Inc. began a recall of Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For... on 2016-06-21. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0686-2017
Classification: Class III
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-12-01
Terminated: 2017-07-01
Recalling firm: Microport Orthopedics Inc.
Product: 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
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 22 units
Distribution: 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.
Product codes and lots: REF 36693646 Serial Numbers: 09230967, 09229086, 10230508 REF 36693848 Serial Numbers: 08228745, 10230509, 11235075 REF 36694050 Serial Numbers: 09229091, 09230501 REF 36694252 Serial Numbers: 09229131, 10230510 REF 36694454 Serial Numbers: LLALMB161A, 09230503 REF 36694656 Serial Numbers: 09230505, 11230847 REF 36694858 Serial Numbers: 09229167, 10230511 REF 36695060 Serial Numbers: 09229169, 09230506 REF 36695262 Serial Numbers: 09230507, 09229170 REF 36695464 Serial Numbers: 08228747, 10230512

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0686-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0683-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0684-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0685-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0686-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0687-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0688-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0689-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code LZO

K100866Class IIProfemur Hip System Modular NecksWrightmedicaltechnologyinc / cleared 2010-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)