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.
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, 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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