Conformis Recalls iTotal Hip Replacement Stems Due to Packaging Error
Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems because sizes 13 and 15 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 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 high-risk medical device where a packaging error could lead to the implantation of an incorrect size, representing a risk of harm even though no injuries have been reported.
Plain-English summary
Conformis, Inc. is recalling two iTotal Hip Replacement System femoral stems, specifically Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right. The recall involves one unit of the product.
The recall was initiated because two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. This packaging error could lead to the implantation of an incorrect stem size for a patient.
The affected products were distributed to consignees in Maryland and Nevada. The source text does not specify the number of patients affected or report any injuries or illnesses. Consumers and healthcare providers should verify the packaging and product size against the surgical plan before use.
The recalled product
- Product
- iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 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)
- 0447621
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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