CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
restor3d Cordera Hip System recalled by Conformis
Conformis is recalling restor3d Cordera Hip System, distributed nationwide in the US. The recall was initiated on 25 Mar 2025 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-1569-2025
- FDA event ID
- 96606
- Recalling firm
- Conformis, Wilmington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2025
- FDA classified
- 15 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 25 Mar 2025 | Recall initiated by company | |
| 15 Apr 2025 | Classified by FDA | +21 days |
| 23 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Product as listed by the FDA
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Where it was distributed
US Nationwide distribution in the states of CA, FL, NV, TN.
Questions about this recall
Is restor3d Cordera Hip System recalled?
Yes. Conformis recalled restor3d Cordera Hip System on 25 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1569-2025.
Why was it recalled?
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Which lots are affected?
Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258
Where was it sold?
US Nationwide distribution in the states of CA, FL, NV, 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
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|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | iTotal Hip Replacement System recalled by Conformis | Conformis | Other | CA |
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 |