The Recall Desk
HighFDA (Devices)·Z-0686-2017·Announced 2016-12-07

MicroPort Lineage Shell Recalled Due to Metal Debris Tissue Reaction Risk

MicroPort Orthopedics is recalling 22 Lineage Shell units due to an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (tissue reaction to metal debris) where specific injury reports are not explicitly detailed in the source text, fitting the criteria for High severity (risk-of-harm products where injury has not yet been reported).

Plain-English summary

MicroPort Orthopedics Inc. is recalling 22 units of the Lineage Shell, a medical device used with the conserve metal head. The affected reference numbers are 36693646, 36693848, 36694050, 36694252, 36694454, 36694656, 36694858, 36695060, 36695262, and 36695464. The recall covers specific serial numbers listed in the agency's structured data.

The recall was initiated because revision rate trends from the MicroPort Orthopedics Inc. database for modular head Metal on Metal THA systems show an increasing overall trend from 2009 to the present. The company identified a specific hazard and harm regarding suspected tissue reaction to metal debris for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

The affected devices were distributed worldwide, including in the United States and numerous international locations such as 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. Patients and healthcare providers should contact MicroPort Orthopedics Inc. for further instructions regarding the recall.

The recalled product

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
Manufacturer
MicroPort Orthopedics Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
22

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by MicroPort Orthopedics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · MicroPort Orthopedics Inc.

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Same hazard · tissue reaction

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