Device product
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Z-1952-2013
Product summary
- Event
- Event 65560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,050
- Official record key
device-enforcement:Z-1952-2013
Official wording
Reason: Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
Code information: All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign material