Recall Z-1775-2019— Conformis, Inc.
Class II · Terminated
Class II FDA medical device recall by Conformis, Inc., initiated 2019-03-29, terminated 2020-04-28. It names one FDA 510(k) clearance: K162719. Product: Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT). Reason: Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants..
- Recalling firm
- Conformis, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-29
- Terminated
- 2020-04-28
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Reason for recall
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Data sourced from openFDA. This site is unofficial and independent of the FDA.