FDA Device Intelligence
HomeDevice types › DZL

Screw, Fixation, Intraosseous

FDA product code DZL · Class 2 · Dental

3,512
Registered devices
1,522
Adverse events
8
Recalls
80
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2016-02-23Synthes (USA) Products LLCOut of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming scr
2016-02-23Synthes (USA) Products LLCOut of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming scr
2013-05-31Synthes USA HQ, Inc.Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bo
2013-01-11Synthes USA HQ, Inc.It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2013-01-11Synthes USA HQ, Inc.It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2013-01-11Synthes USA HQ, Inc.It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
2010-03-17Biomet Microfixation, Inc.Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
2009-10-06Biomet 3i, LLCBiomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufa

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.