Zimmer Biomet Recalls Ankle Implants Due to Packaging Adhesion
Zimmer Biomet is recalling 5.4 million ankle implants because non-highly polished devices 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 source text describes a packaging adhesion issue without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling approximately 5,459,583 units of TM Ankle and Ankle Talus L/R implants. The recall covers all product manufactured prior to January 2014, which was distributed nationwide. The specific item numbers affected are 00450001100, 00450001200, 00450001300, 00450001400, 00450001500, 00450001600, 00450002100, 00450002200, 00450002300, 00450002400, 00450002500, and 00450002600.
The recall was initiated because non-highly polished implants may adhere to the LDPE bag used in the previous packaging configuration. This packaging issue could potentially affect the handling or integrity of the devices.
Healthcare providers and facilities that have received these devices should contact Zimmer Biomet for further instructions on how to proceed. Consumers are not directly affected as these are surgical implants intended for professional medical use.
The recalled product
- Product
- TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
- 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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