Zimmer Biomet Recalls 1.5mm Cranio-maxillofacial Bone Screws for Non-Conforming Slots
Zimmer Biomet is recalling 11 units of 1.5mm Cranio-maxillofacial Bone Screws because the devices were identified as non-conforming with off-centered slots.
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 source text describes a manufacturing defect (non-conforming slots) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 11 units of 1.5mm System, Cranio-maxillofacial Bone Screws (1.5 x 4mm HT SD X-DR Screw). The recall is due to the identification of devices that were non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
The affected devices are identified by Item No. 530430 and Lot 1.5x4mm HT SD X-DR Screw. According to the source text, the distribution pattern indicates no domestic or VA/DOD distribution, with foreign distribution limited to Japan.
Consumers and healthcare providers should stop using these specific devices and contact Zimmer Biomet, Inc. for further instructions or a replacement.
The recalled product
- Product
- 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 11
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)
- 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw
Distribution
Distribution scope not specified by the agency.
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