ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended
FDA device recall Z-0991-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- ConforMIS, Inc.
- Reason for recall
- iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
- Action taken
- ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit. For questions regarding this recall call 781-345-9001.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- Distribution to TX only
- Date initiated
- 2016-10-31
- Date posted
- 2017-01-10
- Date terminated
- 2017-01-11
- Location
- Bedford, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) (K161668) | Conformis, Inc. | 2016-07-15 |