Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
Zimmer Biomet is recalling 445 units of sterile-packaged VERSA-FXII SC TUBE PLT implants due to packaging design verification test failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text cites packaging design verification test failures without reporting specific illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is initiating a field action for 445 units of sterile-packaged VERSA-FXII SC TUBE PLT implants. The affected models include 90DX16H, 95DX16H, 95DX18H, 95DX20H, and 95DX22H. The recall is due to packaging design verification test failures for implants packaged in a single package configuration.
The affected products were distributed domestically across numerous U.S. states and territories, including Puerto Rico, and internationally to countries such as Canada, Australia, China, Germany, and the United Kingdom. Specific lot numbers and item numbers are listed in the recall documentation.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the affected devices.
The recalled product
- Product
- VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 445
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 (6)
- I10K: K954555
- K150818 Item Numbers: 00119309016
- 00119309516
- 00119309518
- 00119309520
- 00119309522
Distribution
Part of a larger recall action
This product is one of 8 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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