MicroPort Orthopedics Recalls Conserve Cups Due to Metal Debris Tissue Reaction
MicroPort Orthopedics is recalling Conserve Cups 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 product (medical device) where injury (tissue reaction) has been identified through trend analysis, but no specific reported illnesses or fatalities are stated in the source text, fitting the 'High' severity criteria.
Plain-English summary
MicroPort Orthopedics Inc. is recalling specific lots of Conserve Cups, which are medical devices used with the Conserve metal head for total hip arthroplasty systems. The recall involves 68,221 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 Inc. database for modular head Metal on Metal Total Hip Arthroplasty (THA) systems. The analysis showed an increasing overall trend from 2009 to the present. The company identified a specific hazard or harm associated with suspected tissue reaction to metal debris, with a rate exceeding one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
Healthcare providers and patients who have received these specific Conserve Cups should contact MicroPort Orthopedics Inc. for further instructions regarding the recall and potential replacement or monitoring options.
The recalled product
- Product
- Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF54
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 68,221
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 38BF3642 Serial Numbers: 1380112
- 1399025
- 1402166
- 1340677
- 1427276
- 1402167
- 1399026
- 1380113
- 1380114
- 1402168
- 1399027
- 1418796
- 1429744
- 1368262
- 1381417
- 1399029
- 1422026
- 1418797
- 1433514
- 1449114
Distribution
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.
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