Date Initiated by Firm | December 18, 2008 |
Date Posted | June 01, 2009 |
Recall Status1 |
Terminated 3 on December 15, 2009 |
Recall Number | Z-1249-2009 |
Recall Event ID |
51422 |
510(K)Number | K021458 |
Product Classification |
craniofacial system instrument - Product Code HRS
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Product | Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. |
Code Information |
Catalog number 530.522S - Lot number TM00324 exp 4/8/10 |
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 | 40 units |
Distribution | Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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