iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Reported: October 16, 2019 Initiated: August 22, 2019 #Z-0063-2020
Product Description
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Reason for Recall
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Details
- Recalling Firm
- Conformis, Inc.
- Units Affected
- 1
- Distribution
- Distributed to consignees in MD and NV.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right. Recalled by Conformis, Inc.. Units affected: 1.
Why was this product recalled? ▼
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0063-2020.
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