FDA Devices Verify with FDA Devices → Moderate Class II Terminated

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0357-2014.

Q: Where was the recalled product distributed?

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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0357-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 6, 2026

Reported: November 27, 2013 Initiated: October 9, 2013 #Z-0357-2014 94 Tray sets units

Zimmer, Inc. issued this FDA Devices recall on November 27, 2013. Classified as Moderate severity (Class II). Approximately 94 Tray sets units are affected. The recall was issued because: Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0357-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on October 9, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 94 Tray sets units are affected.

The documented reason for this recall is: 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 designate… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

94 Tray sets

Related Recalls

6 from same agency

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.

Details

Recalling Firm: Zimmer, Inc.
Units Affected: 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.
Location: Warsaw, IN

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0357-2014
Date reported	November 27, 2013
Date initiated	October 9, 2013
Recalling firm	Zimmer, Inc.
Units affected	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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

94 Tray sets units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0357-2014.

Where was the recalled product distributed? ▼

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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0357-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Guides

Learn how the US recall system works and how to protect yourself and your household.

How the US Recall System Works

The three federal agencies, how recalls are initiated, and what happens next.

Understanding Recall Severity Classes

What Class I, II, and III mean and which recalls demand immediate action.

What to Do When a Product Is Recalled

Verify, claim your remedy, report injuries, and navigate the process.

How to Check If Your Products Are Recalled

Step-by-step guide to checking food, products, medications, and vehicles.

Recalled Products in Your Home

A room-by-room household audit guide for active recalls.

Most Recalled Product Categories

Rankings of highest-recall categories from FDA, CPSC, and NHTSA.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

Explore related product safety and public health data from federal sources.

Food Safety Inspections

FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.

PlainFoodSafe →

Ingredient Safety Data

FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.

PlainIngredients →

Nutrition Data

USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.

GetFoodFacts →

Drug Safety Information

FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.

PlainMeds →

Product Injury Data

CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.

PlainSafety →

Recall Checker

Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.

Check Now →

Recall Radar

Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.

View Radar →

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

FDA Devices Moderate

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18

FDA Devices Low

Penner Pacific Bathing Spa, Model Numbers 360020-1P

Penner Patient Care, Inc. · 2026-03-18

FDA Devices Moderate

GEM Premier 5000 PAK, Part No. 00055360004.

Instrumentation Laboratory · 2026-03-18

FDA Devices Moderate

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Beckman Coulter Mishima K.K. · 2026-03-18

FDA Devices Critical

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…

Trividia Health, Inc. · 2026-03-18

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-06 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).