Date Initiated by Firm |
December 18, 2008 |
Date Posted |
June 01, 2009 |
Recall Status1 |
Terminated 3 on December 15, 2009 |
Recall Number |
Z-1248-2009 |
Recall Event ID |
51422 |
510(K)Number |
K021458
|
Product Classification |
craniofacial system instrument - Product Code HRS
|
Product |
Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. |
Code Information |
Catalog number 530.521S - Lot number TM00322 exp 4/13/11 |
Recalling Firm/ Manufacturer |
Synthes Spine 1302 Wrights Ln E West Chester PA 19380-3417
|
For Additional Information Contact |
Lynne Lewis 610-719-5000
|
Manufacturer Reason for Recall |
The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
|
FDA Determined Cause 2 |
Process control |
Action |
All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail. |
Quantity in Commerce |
26 units |
Distribution |
Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
|