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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Low Profile Neuro Plating System

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 Class 2 Device Recall Synthes Low Profile Neuro Plating Systemsee related information
Date Initiated by FirmFebruary 23, 2016
Date PostedApril 05, 2016
Recall Status1 Terminated 3 on September 08, 2016
Recall NumberZ-1327-2016
Recall Event ID 73561
510(K)NumberK031807 
Product Classification Screw, fixation, intraosseous - Product Code DZL
ProductTitanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Code Information Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833E, Lot numbers: 9958565, 9951621, 9952976, 9955377, 9962314, 9968868, 9969645
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
610-719-6500
Manufacturer Reason
for Recall		Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 23, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were notified by mail of a potential patient impact. They were instructed to review existing inventories and call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization (RA) Number and replacement order. After completing the verification section on page 4 of the letter, they were advised to return the verification section (page 3) with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the completed verification section is to sent to DePuy Synthes by: Fax 877-931-0643 or scan/email Synthes8097@stericycle.com.
Quantity in Commerce150 units distributed in US, 1439 units distributed OUS (foreign)
DistributionWorldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland.
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 = DZL
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