Recall Z-1952-2013— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-06-11, terminated 2015-08-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.. 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..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-11
- Terminated
- 2015-08-31
- Firm location
- West Chester, PA, United States
Product description
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.