Zimmer Biomet Recalls Lineum Translation Screws Due to Incorrect Length Marking
Zimmer Biomet is recalling 64 Lineum 4.35mm x 28mm Translation Screws because the tulip head is incorrectly etched with '24MM' instead of '28MM'.
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 is a minor labeling error (incorrect length marking) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 64 units of the Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728. The recall is due to a manufacturing error where the etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
The affected product is part of the Lineum OCT Spine System, which is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction. The system is also intended to restore the integrity of the spinal column in patients with advanced stage tumors involving the cervical spine.
The recalled units were distributed in the United States to California, North Carolina, and New York, as well as internationally to Germany. The specific lot number is M26888. Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall.
The recalled product
- Product
- Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to resto
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 64
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)
- Lot M26888
Distribution
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