CLASS II Device recall · Reported 8 Apr 2020 · FDA Enforcement Report
iTotal PS Knee Replacement System recalled by Conformis
Conformis is recalling iTotal PS Knee Replacement System, distributed nationwide in the US. The recall was initiated on 3 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1628-2020
- FDA event ID
- 85108
- Recalling firm
- Conformis, Billerica, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2020
- FDA classified
- 1 Apr 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 3 Feb 2020 | Recall initiated by company | |
| 1 Apr 2020 | Classified by FDA | +58 days |
| 8 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Product as listed by the FDA
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is 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.
Where it was distributed
US Nationwide distribution in the states of LA, NY, TN.
Questions about this recall
Is iTotal PS Knee Replacement System recalled?
Yes. Conformis recalled iTotal PS Knee Replacement System on 3 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1628-2020.
Why was it recalled?
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Which lots are affected?
0460018 0460118
Where was it sold?
US Nationwide distribution in the states of LA, NY, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Conformis
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | restor3d Cordera Hip System recalled by Conformis | Conformis | Labeling Errors | Nationwide |
| Device | CLASS II | Identity Imprint PS Tibial Tray Size recalled by Conformis | Conformis | Packaging Defects | Nationwide |
| Device | CLASS II | Hip-screw-, Sterile Eo recalled by Conformis | Conformis | Sterility | Nationwide |
| Device | CLASS II | iTotal Identity Impactor Handle recalled by Conformis | Conformis | Device Malfunction | Nationwide |
| Device | CLASS II | iTotal Identity Posterior Stabilised (PS) Knee Replacement System recalled | Conformis | Packaging Defects | MS |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |