FDAFDA · Food and drugs·Recall number Z-1057-2014
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Published February 26, 2014 · Recall initiated: January 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- USA (nationwide) Distribution.
- Lot
- Part No. 03.010.523, Lot Nos. 8279162 & 8429004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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