Reported Dec 4, 2013 · Terminated
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and…
Synthes USA HQ, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 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.
- Lot codes and dates
- all lots of model number 03.311.001: Part # Synthes lot #
03.311.001193476503.311.001193476603.311.001199384403.311.001303668803.311.001339857603.311.001377648403.311.001510059703.311.001510635403.311.001516087203.311.001516087503.311.001517425303.311.001517425303.311.001517425403.311.001518100003.311.001518100103.311.001519628203.311.001519628303.311.001519708103.311.001524194203.311.001524194303.311.001533672303.311.001536363703.311.001539601603.311.001541147903.311.0015555521
- all lots of model number 03.311.001: Part # Synthes lot #
- Amount recalled
- 369
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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