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U.S. Department of Health and Human Services

Class 2 Device Recall Large Combination Clamp component of Synthes External Fixation System

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  Class 2 Device Recall Large Combination Clamp component of Synthes External Fixation System see related information
Date Initiated by Firm January 11, 2013
Date Posted March 11, 2013
Recall Status1 Terminated 3 on August 31, 2015
Recall Number Z-0941-2013
Recall Event ID 64159
510(K)Number K082650  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Large Combination Clamp/Large External Fixation System, Part Number 390.005

Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Code Information Lot Numbers 6602070, 6582333, 6581191, and 6581193
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact customer support
610-719-5000
Manufacturer Reason
for Recall		 The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email FieldAction@synthes.com
Quantity in Commerce 136
Distribution USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
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.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = SYNTHES (USA)
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