• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
LCP Volar Distal Radius Plate Extra Articular 4H HDRTLong
see related information
Date Posted January 11, 2007
Recall Status1 Terminated on February 13, 2007
Recall Number Z-0489-2007
Recall Event ID 37010
Premarket Notification
510(K) Number
K012114 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
Code Information Catalog number 242.465, Lot number 5373486
Recalling Firm/
Manufacturer
Synthes
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Scott Eden
800-620-7025
Manufacturer Reason
for Recall
Hole is malformed, leading to reduced construct strength.
FDA Determined
Cause 2
DESIGN: Software Design
Action All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.
Quantity in Commerce 11 units
Distribution The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = SYNTHES (USA)
-
-