Zimmer, Inc.: 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.

Recall number

Z-0357-2014

Recalling firm

Zimmer, Inc.

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.

Status

Terminated

Initiated

2013-10-09

Posted

2013-11-18

Terminated

2015-02-24

Reason

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

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 CorporateQuality.Postmarket@zimmer.com. For assistance or questions, contact Zimmer Spine Customer Service at 866-774-6368.

Quantity

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.

Lot, serial or model codes

Lots: P060509, P061255, P070617, P080422, P090046

510(k) numbers

["K061353"]

PMA numbers

not on file

Product code

KWQ

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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