The Recall Desk
HighFDA (Devices)·Z-0687-2017·Announced 2016-12-07

MicroPort Recalls Conserve Hip Shells Due to Metal Debris Tissue Reaction

MicroPort Orthopedics is recalling Conserve hip shells because revision rate trends indicate 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 medical device where a specific hazard (tissue reaction to metal debris) is identified, but the source text does not report specific injuries, hospitalizations, or deaths, nor does it classify the recall as FDA Class I.

Plain-English summary

MicroPort Orthopedics Inc. is recalling specific lots of Conserve Shells, which are used with the Conserve metal head in total hip arthroplasty systems. The recall covers 68,199 units distributed worldwide, including in the United States and numerous international markets.

The recall was initiated after an evaluation of revision rate trends within the MicroPort Orthopedics database showed an increasing overall trend from 2009 to the present. The analysis identified a specific hazard or harm associated with suspected tissue reaction to metal debris for modular head CONSERVE systems and DYNASTY metal acetabular liner systems.

Patients who have received these specific Conserve Shells should contact their healthcare provider to discuss the findings and determine if further evaluation or intervention is necessary.

The recalled product

Product
Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 380244
Manufacturer
MicroPort Orthopedics Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
68,199

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 38021146 Serial Numbers: 02210174
  • 09217496
  • 01333507
  • 02334561
  • 03336229
  • 04338462
  • 05340904
  • 05341951
  • 10349882
  • 11351847
  • 04460698
  • 04460243
  • 06480454
  • 07488190 REF 38021148 Serial Numbers: 02210175
  • 05216035
  • 11228750
  • 01334562
  • 02336230
  • 03338463
  • 05340563

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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