CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Synthes Tensioning Device The Synthes Osteogenesis System recalled
Synthes USA HQ is recalling Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for, distributed nationwide in the US. The recall was initiated on 31 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-0388-2014
- FDA event ID
- 66420
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2013
- FDA classified
- 25 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 31 Jul 2013 | Recall initiated by company | |
| 25 Nov 2013 | Classified by FDA | +117 days |
| 4 Dec 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
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 Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
Which lots are affected?
all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521
Where was it sold?
Nationwide Distribution.
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 | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |