The Recall Desk
ModerateFDA (Devices)·Z-0689-2017·Announced 2016-12-07

MicroPort Recalls Cobalt Chromium Hip Replacement Heads Due to Metal Debris Risk

MicroPort Orthopedics is recalling specific Cobalt Chromium hip replacement heads because internal data showed an increasing trend in revision rates and a specific hazard of 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 recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The source notes a specific hazard of tissue reaction to metal debris, which supports a Moderate (2) rather than Low (1) rating.

Plain-English summary

MicroPort Orthopedics Inc. is recalling specific lots of Cobalt Chromium Heads used in Transcend and Conserve modular head Metal on Metal Total Hip Arthroplasty (THA) systems. The recall involves 108,362 units that were distributed worldwide, including in the United States and numerous international markets.

The recall was initiated after the company evaluated revision rate trends within its database. The analysis revealed an increasing overall trend in revisions from 2009 to the present. Additionally, the evaluation identified a specific hazard or harm associated with suspected tissue reaction to metal debris, with rates exceeding one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Patients who have had these specific hip replacement components implanted should contact their healthcare provider to discuss the findings and determine if any further action is necessary. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product
Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404
Manufacturer
MicroPort Orthopedics Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
108,362

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)

  • Transcend REF 26000017 Serial Numbers: 1392035
  • 1394262
  • 1403269
  • 1404128
  • 1405348
  • 1406868
  • 1416193
  • 1416410
  • 416916
  • 1417966
  • 1421701
  • 1424398
  • 1427395
  • 1429561
  • 1432313
  • 1432727
  • 1435174
  • 1436773
  • 1437714
  • 1444931

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 · metal debris

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