CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Synthes Titanium Cannulated Humeral Nail Intended to aid recalled
Synthes USA HQ is recalling Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and, 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-0407-2014
- FDA event ID
- 66419
- 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
- Packaging Defects
- Device type
- Heart & Vascular 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 packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Where it was distributed
Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
Nationwide AlabamaIowaKentuckyNorth CarolinaPennsylvaniaSouth CarolinaTexasVirginia
Questions about this recall
Why was it recalled?
The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
Which lots are affected?
Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517
Where was it sold?
Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, 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 26 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
All 56| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ | Synthes USA HQ | Foreign Material | Nationwide |
| Device | CLASS II | Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled | Synthes USA HQ | Other | Nationwide |
| Device | CLASS II | Synthes Trochanteric Fixation Nail As part of the Synthes recalled | Synthes USA HQ | Labeling Errors | Nationwide |
| Device | CLASS II | Synthes Soft Tissue Retractor Small Extendible recalled | Synthes USA HQ | Device Malfunction | Nationwide |
| Device | CLASS II | Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ | Synthes USA HQ | Other | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |