Agency classClass IIIOur severity:High FDA (Devices)·Z-0684-2017·Announced 2016-12-07

MicroPort Dynasty Liners Recalled Due to Metal Debris Tissue Reaction Risk

MicroPort Orthopedics is recalling 6,250 Dynasty Liners used in hip replacements due to an increasing trend of suspected tissue reactions to metal debris.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device with a reported hazard of tissue reaction to metal debris, which is a risk-of-harm condition where specific injury counts are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

MicroPort Orthopedics Inc. is recalling 6,250 units of Dynasty Liners, which are used with the Conserve metal head in total hip arthroplasty (THA) systems. The affected products include specific reference numbers ranging from DLCOGA28 to DLCOGK56, distributed worldwide including the United States, Canada, and numerous 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 of suspected tissue reaction to metal debris exceeding one percent for modular head Conserve systems and Dynasty metal acetabular liner systems.

Patients who have received these specific implants should contact their healthcare provider to discuss the findings and determine if further evaluation or intervention is necessary. The recall covers specific serial numbers listed in the official FDA notice.

The recalled product

Product: Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
Manufacturer: MicroPort Orthopedics Inc.
Category: Medical Device — Orthopedic Implant
Hazard: tissue-reaction
metal-debris
Affected units: 6,250

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)

Serial Numbers: REF DLCOGA28 Seral Numbers: 1509498
1509897
107461555
117476083
127477625
0411341968
0611341969
0901199714 REF DLCOGB32 Serial Numbers: 1428321
027403682
027403684
027412214
027412216
027412218
027412220
027412222
029789268
048571448
058605178
068625411
069837383

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 →

Same manufacturer · MicroPort Orthopedics Inc.

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