CLASS III Device recall · Reported 7 Dec 2016 · FDA Enforcement Report
Lineage Shell recalled by MicroPort Orthopedics
MicroPort Orthopedics is recalling Lineage Shell, distributed nationwide in the US. The recall was initiated on 21 Jun 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0686-2017
- FDA event ID
- 75063
- Recalling firm
- MicroPort Orthopedics, Arlington, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Jun 2016
- FDA classified
- 1 Dec 2016
- Reported
- 7 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 21 Jun 2016 | Recall initiated by company | |
| 1 Dec 2016 | Classified by FDA | +163 days |
| 7 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 75063This product is part of a recall event; the main page for the event is Dynasty Liners recalled by MicroPort Orthopedics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Dynasty Liners recalled by MicroPort Orthopedics | MicroPort Orthopedics | Foreign Material | Nationwide | |
| CLASS III | Procotyl (Rim- Lock) Liners recalled by MicroPort Orthopedics | MicroPort Orthopedics | Foreign Material | Nationwide | |
| CLASS III | Conserve Cups recalled by MicroPort Orthopedics | MicroPort Orthopedics | Foreign Material | Nationwide | |
| CLASS III | Conserve Shells recalled by MicroPort Orthopedics | MicroPort Orthopedics | Foreign Material | Nationwide | |
| CLASS III | Lineage Liners recalled by MicroPort Orthopedics | MicroPort Orthopedics | Foreign Material | Nationwide |
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