FDA Medical Device Recalls (openFDA)
Synthes, Inc.: Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
- Recall number
- Z-1174-2014
- Recalling firm
- Synthes, Inc.
- Product
- Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
- Status
- Terminated
- Initiated
- 2014-01-27
- Posted
- 2014-03-11
- Terminated
- 2016-08-26
- Reason
- Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
- Root cause
- Labeling design
- Action
- Synthes sent an Urgent Medical Medical Device Recall letter, dated January 27, 2013, to Users and Sales Consultants. The letter identified the affected product, reason for recall, potential hazard, and actions to be taken. Customers were instructed to complete the verification section. For questions call 610-719-5450 or contact your Synthes Sales Consultant. .
- Quantity
- 18747
- Distribution
- USA Nationwide Distribution
- Lot, serial or model codes
- All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425.
- 510(k) numbers
- ["K915818"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3005180112
- 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