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'.
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, 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…
- 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
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBiomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues
FDA (Devices) · 2015-09-16
- HighZimmer Biomet Recalls Virage OCT Spinal Fixation System Due to Set Screw Defect
FDA (Devices) · 2016-01-20
- HighZimmer Biomet Recalls Altius M-INI OCT Spinal Fixation System
FDA (Devices) · 2017-04-05
- HighBiomet Spine Recalls Out-of-Specification 5.5 mm Rod Set Screws
FDA (Devices) · 2015-03-04
- HighSpinal Implant Screws Recalled Due to Potential Weld Failure
FDA (Devices) · 2022-12-14
- ModerateZimmer Biomet Recalls Mobi-C Distraction Screws Due to Labeling Error
FDA (Devices) · 2019-06-26