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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 2 Recall
LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long
see related information
Date Posted January 11, 2007
Recall Number Z-0489-2007
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
Reason for
Recall
Hole is malformed, leading to reduced construct strength.
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.
 
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