Z-0357-2014 Class II Terminated
FDA device recall Z-0357-2014 was initiated by Zimmer, Inc. on Oct 9, 2013 and is designated Class II. Reason for recall: Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left… The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 94 Tray sets.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2013
- Initiation Date
- Oct 9, 2013
- Termination Date
- Feb 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94 Tray sets
Product Description
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
Reason for Recall
Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Nationwide and OUS countries include: Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and the UK.
Code Information
Lots: P060509, P061255, P070617, P080422, P090046
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0357-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026