Z-1327-2016Class II

Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E

Name: Z-1327-2016 Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E
Creator: Synthes (USA) Products LLC
Published: 2016-02-23
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-02-23 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use... on 2016-02-23. FDA classified it as Class II and gives the reason as "Out 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 screws such that the thread height of the screws is undersized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1327-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Posted: 2016-04-05
Terminated: 2016-09-08
Recalling firm: Synthes (USA) Products LLC
Product: Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Product code: DZL Screw, Fixation, Intraosseous
Reason for recall: Out 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 screws such that the thread height of the screws is undersized.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 23, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were notified by mail of a potential patient impact. They were instructed to review existing inventories and call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization (RA) Number and replacement order. After completing the verification section on page 4 of the letter, they were advised to return the verification section (page 3) with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the completed verification section is to sent to DePuy Synthes by: Fax 877-931-0643 or scan/email [email protected].
Quantity in commerce: 150 units distributed in US, 1439 units distributed OUS (foreign)
Distribution: Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland.
Product codes and lots: Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833E, Lot numbers: 9958565, 9951621, 9952976, 9955377, 9962314, 9968868, 9969645

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1327-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1326-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05
Z-1327-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code DZL

K031807Class IISynthes Low Profile Neuro System - 3 Mm ScrewsSynthes (Usa) / cleared 2003-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)