Zimmer Biomet Recalls Mobi-C Distraction Screws Due to Labeling Error
Zimmer Biomet is recalling 313 Mobi-C 14mm Distraction Screws because they were incorrectly labeled as 12mm length screws.
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, but the hazard is a minor labeling error (incorrect length description) with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Zimmer Biomet, Inc. is recalling 313 units of the Mobi-C 14mm Distraction Screw, Quick Start (Item Number: 0024-LDR). The device is intended for cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7. The recall was initiated because an additional label on the packaging incorrectly described the 14mm length part as a 12mm length screw.
The affected units are from Lot Number 2017102450. The products were distributed nationwide in the United States by LDR Spine USA, Inc. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should check their inventory and records for the specific lot number and item number listed above. If the device has already been implanted, patients should contact their healthcare provider for guidance. The recall is limited to the specific units identified in the source text.
The recalled product
- Product
- Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 313
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 Number: 2017102450
Distribution
Distributed nationwide across the United States.
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