Z-0474-2014 Class II Terminated
FDA device recall Z-0474-2014 was initiated by Synthes USA HQ, Inc. on Jul 30, 2013 and is designated Class II. Reason for recall: Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. The recall status is terminated (terminated Sep 10, 2015). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 18, 2013
- Initiation Date
- Jul 30, 2013
- Termination Date
- Sep 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product Description
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Reason for Recall
Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
Distribution Pattern
Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Code Information
Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.