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Recall Observatory FDA recall evidence

Device product

Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

Z-1952-2013

June 11, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign material