CLASS II Device recall · Reported 20 Feb 2019 · FDA Enforcement Report
Genius Knee Cemented Tibial Component recalled
Signature Orthopedics Pty is recalling Genius Knee Cemented Tibial Component, distributed nationwide in the US. The recall was initiated on 10 Dec 2018 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-0833-2019
- FDA event ID
- 81967
- Recalling firm
- Signature Orthopedics Pty, Lane Cove West, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Dec 2018
- FDA classified
- 14 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 10 Dec 2018 | Recall initiated by company | |
| 14 Feb 2019 | Classified by FDA | +66 days |
| 20 Feb 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product mix up
Product as listed by the FDA
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Where it was distributed
US Nationwide Distribution in the states of FL, NY, and TN
Questions about this recall
Is Genius Knee Cemented Tibial Component recalled?
Yes. Signature Orthopedics Pty recalled Genius Knee Cemented Tibial Component on 10 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0833-2019.
Why was it recalled?
Product mix up
Which lots are affected?
UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F
Where was it sold?
US Nationwide Distribution in the states of FL, NY, and 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 Signature Orthopedics Pty
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Logical cup liner recalled by Signature Orthopedics Pty | Signature Orthopedics Pty | Labeling Errors | Nationwide |
| Device | CLASS II | Genius Knee Cemented CR Femoral Component recalled | Signature Orthopedics Pty | Other | Nationwide |
| Device | CLASS II | Signature Ceramic Femoral Head recalled by Signature Orthopedics Pty | Signature Orthopedics Pty | Labeling Errors | Nationwide |
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 |