Zimmer Biomet Recalls Spinal Plates Due to Packaging Adhesion
Zimmer Biomet is recalling specific spinal plates because non-highly polished implants may adhere to the packaging bag.
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 the hazard involves packaging adhesion without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific spinal plates (SM DIS VOL/DORS RAD LAT COL PLATE) under FDA recall number Z-0311-2020. The recall involves 5,459,583 total devices that were distributed nationwide. The affected products are all items manufactured prior to January 2014.
The recall is being conducted because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue is associated with the specific item numbers listed in the recall notice.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or return of these devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,459,583
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 (1)
- All product manufactured prior to January 2014.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 41 products in this recall →Related recalls
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