The Recall Desk
ModerateFDA (Devices)·Z-0683-2017·Announced 2016-12-07

MicroPort Orthopedics Recalls Lineage Liners Due to Metal Debris Tissue Reaction

MicroPort Orthopedics is recalling 5,009 Lineage Liners used with Conserve metal heads due to a suspected tissue reaction to metal debris.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The source notes a suspected tissue reaction but does not report specific injuries or deaths, placing it in the moderate range for a precautionary medical device recall.

Plain-English summary

MicroPort Orthopedics Inc. is recalling 5,009 units of Lineage Liners (REF 70102846, 70202852, 70302858, 70303258, 70402864, 70403264, and 70403664) intended for use with the Conserve metal head. The recall covers units distributed worldwide, including the United States, Canada, Australia, and various countries in Europe, Asia, and South America.

The recall was initiated because revision rate trends from the manufacturer's database indicate an increasing overall trend from 2009 to the present. Specifically, the data identified a hazard or harm associated with a suspected tissue reaction to metal debris for modular head Conserve systems and Dynasty metal acetabular liner systems.

Patients who have had these specific liners implanted should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if further evaluation or intervention is necessary. The FDA has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences, but the manufacturer is taking action to correct or remove the product to comply with quality control standards.

The recalled product

Product
Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
Affected units
5,009

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 (20)

  • REF 70102846 Serial numbers: 06217334
  • 06217335
  • 06217336
  • 07218879
  • 10229555
  • 12339970
  • 12342378
  • 09345262
  • 11356669
  • 03459689
  • 03460757
  • 05478476
  • 06487845
  • 09491060
  • 11497839
  • 114131987
  • 025179937
  • 035198678
  • 035199154
  • 075211008

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 →