Recall Z-0731-2019— Conformis, Inc.
Class II · Terminated
Class II FDA medical device recall by Conformis, Inc., initiated 2018-10-16, terminated 2020-06-29. It names one FDA 510(k) clearance: K162719. Product: iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101. Reason: The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm..
- Recalling firm
- Conformis, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-16
- Terminated
- 2020-06-29
- 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
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Reason for recall
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.