1.5mm System recall
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Why was 1.5mm System recalled?
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw
- Product
- 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 11
- Distribution
- Domestic: None VA/DOD: None Foreign: Japan
- Recall date
- February 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)