FDA Device recall Z-0600-2018
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/… by Conformis, citing implant kit mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0600-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-24 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conformis |
| Distribution | CA, TX |
Product
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ 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 that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Reason
Implant kit mislabeled
Identifiers
| code_info | Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017 |
|---|
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-0600-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.