Z-0357-2014Class II

Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior...

Name: Z-0357-2014 Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior...
Creator: Zimmer, Inc.
Published: 2013-10-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-10-09 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental... on 2013-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0357-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-09
Posted: 2013-11-18
Terminated: 2015-02-24
Recalling firm: Zimmer GmbH
Product: 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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer Spine sent a Medical Device Correction letter dated October 9, 2013 via FedEx A Medical Device Correction letter, dated October 09, 2013 via FedEx to distributors, Hospitals and Surgeons who have received and/or used the device. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of its contents. Only sterilize the Ratchet Handles external to the instrument tray. Customers were to be notified when replacement trays were available. Customer with questions were instructed to call the Zimmer Customer Call Center at 866-774-6368. UPDATE: July 17, 2014 Zimmer issued another letter to consignees to inform them of a redesigned tray is available and will replace the current tray. A Zimmer representative will conduct the swap-out of the current Rev A tray for the new Rev B design tray. A Return Confirmation Form is asked to be emailed back to [email protected]. For assistance or questions, contact Zimmer Spine Customer Service at 866-774-6368.
Quantity in commerce: 94 Tray sets
Distribution: 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.
Product codes and lots: Lots: P060509, P061255, P070617, P080422, P090046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0357-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0357-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code KWQ

K061353Class IITrinica Anterior Lumbar Plate SystemZimmer Spine, Inc. / cleared 2006-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)