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U.S. Department of Health and Human Services

Class 3 Device Recall 1.5x4mm HT XDrive Screw

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  Class 3 Device Recall 1.5x4mm HT XDrive Screw see related information
Date Initiated by Firm March 17, 2010
Date Posted August 11, 2010
Recall Status1 Terminated 3 on August 11, 2010
Recall Number Z-2206-2010
Recall Event ID 54370
510(K)Number K953385  
Product Classification Intraosseous Fixation Screw - Product Code DZL
Product BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.

BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW.BIOMETMICROFIXATION.COM.

Intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Code Information Lot 148530
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact
904-741-4400
Manufacturer Reason
for Recall		 Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
FDA Determined
Cause 2		 Other
Action Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.
Quantity in Commerce 1247 screws
Distribution Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.
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 = DZL and Original Applicant = WALTER LORENZ SURGICAL, INC.
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