Conformis iTotal Hip Replacement Stems Recalled for Packaging Error
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems (sizes 13 and 15) because they were packed in each other's packaging.
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: This is a Class II recall involving a packaging/labeling error (switched stems) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling/packaging issues.
Plain-English summary
Conformis, Inc. is recalling two iTotal Hip Replacement System femoral stems, specifically the Size 13 and Size 15 Patient Specific Stems (Right). The recall is due to a packaging error where the two stems were erroneously switched and packed in each other's packaging.
The affected units were distributed to consignees in Maryland and Nevada. The recall number is Z-0063-2020.
Healthcare providers and patients should verify the size and model of the implanted or pending implant against the packaging to ensure the correct device is used. If a mismatch is identified, contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- Manufacturer
- Conformis, Inc.
- Affected units
- 1
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 (1)
- 0448088
Distribution
Part of a larger recall action
This product is one of 2 recalled by Conformis, 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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