ArthroCare Recalls TOPAZ MicroDebrider Devices Due to Shelf-Life Failure
ArthroCare Corporation is recalling 26,903 TOPAZ MicroDebrider devices because they failed to meet shelf-life requirements at their expiration dates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a failure to meet shelf-life, which is a performance defect rather than an acute safety hazard like a structural failure or contamination.
Plain-English summary
ArthroCare Corporation is recalling 26,903 units of TOPAZ MicroDebrider devices, including the 0.8 mm, IFS 0.8 mm, and EPF MicroDebrider 0.8 mm 45 models. The recall affects specific lot codes listed in the agency's structured data.
The recall was initiated after functional testing of the devices following real-time aging revealed that the products failed to meet the shelf-life indicated on their labels. This means the devices may not perform as intended when used at or after their expiration dates.
The affected devices were distributed nationwide in the United States and in numerous countries worldwide, including locations in Europe, Asia, the Middle East, South America, and Africa. Users should stop using the affected devices and contact ArthroCare Corporation for instructions on return or replacement.
The recalled product
- Product
- TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
- Manufacturer
- ArthroCare Corporation
- Hazard
- Affected units
- 26,903
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)
- 1031506
- 1031507
- 1032123
- 1032325
- 1032741
- 1032742
- 1033443
- 1033965
- 1033966
- 1034397
- 1039120
- 1041765
- 1044089
- 1044090
- 1045862
- 1048237
- 1048933
- 1049185
- 1052071
- 1056212
Distribution
Distributed nationwide across the United States.
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