Z-0387-2014 Class II Terminated
FDA device recall Z-0387-2014 was initiated by Synthes USA HQ, Inc. on Jul 31, 2013 and is designated Class II. Reason for recall: The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. The recall status is terminated (terminated Jun 1, 2015). Affected quantity: 135.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 31, 2013
- Termination Date
- Jun 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135
Product Description
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
Reason for Recall
The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.
Distribution Pattern
US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.
Code Information
Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538