CLASS II Device recall · Reported 11 Dec 2013 · FDA Enforcement Report
Synthes Soft Tissue Retractor Small Extendible recalled
Synthes USA HQ is recalling Synthes Soft Tissue Retractor Small Extendible, distributed nationwide in the US. The recall was initiated on 1 Aug 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-0429-2014
- FDA event ID
- 66530
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2013
- FDA classified
- 29 Nov 2013
- Reported
- 11 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 1 Aug 2013 | Recall initiated by company | |
| 29 Nov 2013 | Classified by FDA | +120 days |
| 11 Dec 2013 | 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
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
Questions about this recall
Is Synthes Soft Tissue Retractor Small Extendible recalled?
Yes. Synthes USA HQ recalled Synthes Soft Tissue Retractor Small Extendible on 1 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0429-2014.
Why was it recalled?
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
Which lots are affected?
Part J5957AC (old), and Part J5957F (new)
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
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 Synthes USA HQ
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|---|---|---|---|---|---|
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