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Terminated

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.

FDA Recall Z-1174-2014 · Posted 2014-03-11

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2014-01-27
Date Terminated2016-08-26
Product Quantity18747

Reason for Recall

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.

Firm 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. .

Root Cause

Labeling design

Distribution Pattern

USA Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915818SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATESynthes (Usa) · 1992-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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