CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Synthes LCP Curved Condylar Plate Intended recalled by Synthes USA HQ
Synthes USA HQ is recalling Synthes LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur, distributed nationwide in the US. The recall was initiated on 30 Jul 2013 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-0409-2014
- FDA event ID
- 66418
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2013
- FDA classified
- 26 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Jul 2013 | Recall initiated by company | |
| 26 Nov 2013 | Classified by FDA | +119 days |
| 4 Dec 2013 | 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 Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
Product as listed by the FDA
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Where it was distributed
Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
Questions about this recall
Is Synthes LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur recalled?
Yes. Synthes USA HQ recalled Synthes LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur on 30 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0409-2014.
Why was it recalled?
The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
Which lots are affected?
Part No. 02.001.324, lot no. 6900823
Where was it sold?
Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
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.
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