iTotal Hip Replacement System (CONFORMIS) – Packaging Swap Error (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
0448088
Products Sold
0448088
Conformis, Inc. is recalling iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right due to Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Recommended Action
Per FDA guidance
Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MD, NV
Page updated: Jan 10, 2026