Zimmer Trinica Anterior Lumbar Plate Instrument Tray Recall for Sterilization Issues
Zimmer Spine is recalling Trinica ALP Instrument Trays because ratchet handles may not sterilize effectively due to tray design interference.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterilization failure of surgical instruments. No injuries or illnesses are reported in the source text, and the hazard is a theoretical risk of inadequate sterilization rather than a confirmed defect causing harm.
Plain-English summary
Zimmer Spine, Inc. is initiating a correction for the Trinica ALP Instrument Tray, part 07.01058.001, across all lots. The recall involves 94 tray sets that were distributed nationwide in the United States and internationally to countries including Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and the UK.
The recall is due to a design issue where the current bracketing in the tray may interfere with complete steam penetration into the cannulated ratchet handles (part 07.00438.001). This interference may prevent the handles from being effectively sterilized if they are left in their designated locations within the tray.
The affected product is a temporary supplemental fixation device used for spinal correction and stabilization. The system consists of plates and screws made from titanium alloy. The recall is classified as Class II by the FDA. Healthcare facilities and users should contact Zimmer Spine for instructions on how to proceed with the affected trays.
The recalled product
- 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 i
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 94
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: P060509
- P061255
- P070617
- P080422
- P090046
Distribution
Distributed nationwide across the United States.
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