Zimmer Biomet Recalls Tibial Plates Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million tibial 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, but the hazard is a packaging adhesion issue without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling approximately 5,459,583 Periarticular Plates - Tibial. The recall covers all product manufactured prior to January 2014 and includes specific item numbers listed in the agency record. These devices were distributed nationwide.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag, which was the previous packaging configuration. This issue is specific to the interaction between the implant surface and the packaging material.
Healthcare providers and patients who have these specific tibial plates implanted or in inventory should contact Zimmer Biomet for instructions on how to proceed. The company is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234
- 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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