CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Synthes TI Va-lcp Crvd Condylar Plate/6H//Rt-ster Synthes recalled
Synthes USA HQ is recalling Synthes TI Va-lcp Crvd Condylar Plate/6H//Rt-ster Synthes TI Va-lcp Crvd Condylar, distributed in Colorado. The recall was initiated on 29 May 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-0401-2014
- FDA event ID
- 66723
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2013
- FDA classified
- 26 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 May 2013 | Recall initiated by company | |
| 26 Nov 2013 | Classified by FDA | +181 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
A plate was inadvertently released to a sales consultant that was restricted for sale.
Product as listed by the FDA
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Where it was distributed
US Distribution in Colorado.
Questions about this recall
Is Synthes TI Va-lcp Crvd Condylar Plate/6H//Rt-ster Synthes TI Va-lcp Crvd Condylar recalled?
Yes. Synthes USA HQ recalled Synthes TI Va-lcp Crvd Condylar Plate/6H//Rt-ster Synthes TI Va-lcp Crvd Condylar on 29 May 2013. The recall is Class II and its status is Terminated. Recall number Z-0401-2014.
Why was it recalled?
A plate was inadvertently released to a sales consultant that was restricted for sale.
Which lots are affected?
part 04.124.406S, lot 3771678.
Where was it sold?
US Distribution in Colorado.
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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