FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 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.
- Recall number
- Z-1327-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-02-23
- Posted
- 2016-04-05
- Terminated
- 2016-09-08
- Reason
- 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
- 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 Synthes8097@stericycle.com.
- Quantity
- 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.
- Lot, serial or model codes
- Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833E, Lot numbers: 9958565, 9951621, 9952976, 9955377, 9962314, 9968868, 9969645
- 510(k) numbers
- ["K031807"]
- PMA numbers
- not on file
- Product code
- DZL
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28