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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall LCP Volar Distal Radius Plate Extra Articular 4H HDRTLongsee related information
Date Initiated by FirmDecember 05, 2006
Date PostedJanuary 11, 2007
Recall Status1 Terminated 3 on February 13, 2007
Recall NumberZ-0489-2007
Recall Event ID 37010
510(K)NumberK012114 
Product Classification bone fixation plate - Product Code HRS
ProductLCP 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 PA 19380-3417
For Additional Information ContactScott Eden
800-620-7025
Manufacturer Reason
for Recall
Hole is malformed, leading to reduced construct strength.
FDA Determined
Cause 2
Other
ActionAll 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 Commerce11 units
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = HRS
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