CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report
Logical cup liner recalled by Signature Orthopedics Pty
Signature Orthopedics Pty is recalling Logical cup liner, distributed nationwide in the US. The recall was initiated on 20 Apr 2021 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-1694-2021
- FDA event ID
- 87862
- Recalling firm
- Signature Orthopedics Pty, Lane Cove West
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2021
- FDA classified
- 28 May 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 20 Apr 2021 | Recall initiated by company | |
| 28 May 2021 | Classified by FDA | +38 days |
| 9 Jun 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product mislabeled, with the incorrect product inside the package.
Product as listed by the FDA
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Where it was distributed
US Nationwide distribution in the state of NC.
Questions about this recall
Is Logical cup liner recalled?
Yes. Signature Orthopedics Pty recalled Logical cup liner on 20 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1694-2021.
Why was it recalled?
Product mislabeled, with the incorrect product inside the package.
Which lots are affected?
LOT# 71541-1
Where was it sold?
US Nationwide distribution in the state of NC.
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 | Genius Knee Cemented CR Femoral Component recalled | Signature Orthopedics Pty | Other | Nationwide |
| Device | CLASS II | Genius Knee Cemented Tibial 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 |