Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
FDA Recall Z-1312-2016 · Posted None
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeFZX
Date Initiated2016-02-16
Date Terminated2016-12-07
Product Quantity42 plate systems
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
Firm 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: [email protected].
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.