iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
This recall has been terminated (originally issued August 22, 2019).
- Company
- Conformis, Inc.
- Recall Initiated
- August 22, 2019
- Terminated
- July 8, 2020
- Recall Number
- Z-0063-2020
- Quantity
- 1
- Firm Location
- Billerica, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Distribution
Distributed to consignees in MD and NV.
Lot / Code Info
0448088
Root Cause
Under Investigation by firm
Action Taken
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.
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