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U.S. Department of Health and Human Services

Class 2 Device Recall Titanium Surfix Alpha Screws

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  Class 2 Device Recall Titanium Surfix Alpha Screws see related information
Date Initiated by Firm December 21, 2011
Date Posted March 02, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-1147-2012
Recall Event ID 61125
510(K)Number K083154  
Product Classification Plate, fixation, bone - Product Code HRS
Product Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile, or as one (1) unit which is kitted within an instrumentation tray at which point, the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint.
Code Information Model #295214S, Part #295214SND, Batch #EGH9
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Sean Luland
609-275-0500
Manufacturer Reason
for Recall		 Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.
FDA Determined
Cause 2		 Error in labeling
Action Integra contacted the Sales Representatives and All USERS on December 21, 2011, with a 'SUBJECT: MEDICAL DEVICE RECALL' letter. The letter was sent via FedEx and/or E-mail. The letter describes the product, problem, and the actions to be taken by the customers and the firm. The customers are instructed to immediately examine their inventories for the presence of the recalled product, and complete and return the attached, MEDICAL DEVICE RECALL ACKNOWLEDGMENT AND RETURN FORM via E-mail or FAX #1-609-0750-7999. Any questions concerning the recall document are to be addressed to the customers' regional managers or to the E-mail address and/or telephone number provided on the recall notification.
Quantity in Commerce 105 units
Distribution Nationwide Distribution, USA - including the states of OH, FL, WI, CT, OK, TN, OR, ID, CA, PA, MD, VA, FL, MS, NJ, LA, IA, GA, AL, MA, NY, MN, TN, IL, AR, NE, AZ, MI, WA, OR, NC, KY, MO, UT, NV, IN, SC, CO and the countries of the United Kingdom, France, Switzerland, and Austria.
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 = HRS and Original Applicant = NEWDEAL SAS
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