FDA Device recall Z-0658-2017
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111
- FDA Device
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111 by Conformis, citing mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0658-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-18 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conformis |
| Distribution | CO, NV |
Product
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Reason
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Identifiers
| code_info | Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2017%22
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