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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Interlocking Bolt, 151mm

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  Class 2 Device Recall Synthes Interlocking Bolt, 151mm see related information
Date Initiated by Firm February 16, 2016
Create Date March 31, 2016
Recall Status1 Terminated 3 on December 07, 2016
Recall Number Z-1312-2016
Recall Event ID 73600
Product Classification Guide, surgical, instrument - Product Code FZX
Product Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Code Information Lot Number# 1776197 (5706588), 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197, the part is etched with 1776197; the package label documents 5706588.
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact David Carvin
610-719-5443
Manufacturer Reason
for Recall		 DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi
FDA Determined
Cause 2		 Device Design
Action DePuy Synthes sent an Urgent Notice to inform customers that they were initiating a voluntary recall of lot numbers: 1776197, 5706588, 1782340 and 1868678 of the Interlocking Bolt which are part of the Synthes 4.5mm LCP Proximal Tibia Plate System. Customers were asked to review their inventory for the affected lots, call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verifcation Section (page 3 of the letter) identifying that the affected product has been located and return it to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the Verification Section of the letter was to be faxed to 866-737-4701 or emailed to: Synthes2856@stericycle.com.
Quantity in Commerce 42 plate systems
Distribution Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
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.
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