Zimmer Biomet Recalls Prox Lat Humeral Lock Plates Due to Packaging Adhesion
Zimmer Biomet is recalling Prox Lat Humeral Lock Plates because non-highly polished implants may adhere to the LDPE bag packaging.
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, but the source text explicitly states no illnesses or injuries are reported and the hazard is limited to packaging adhesion, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling the PROX LAT HUMERAL LOCK PLATE, including specific item numbers 47235800104 through 47235800212. The recall involves 5,459,583 total devices that were distributed nationwide. All affected products were manufactured prior to January 2014.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration for these devices. This adhesion issue is the specific reason for the recall action.
Healthcare providers and patients who have these specific implants should contact Zimmer Biomet for further instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212
- 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.
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