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U.S. Department of Health and Human Services

Class 2 Device Recall Gold Slotted Screw

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 Class 2 Recall
Gold Slotted Screw
see related information
Date Posted July 06, 2010
Recall Status1 Terminated on August 30, 2010
Recall Number Z-1956-2010
Recall Event ID 54371
Premarket Notification
510(K) Number
K874400 
Product Classification Screw, Fixation, Intraosseous - Product Code DZL
Product BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.
Code Information Lots 868517, 865348, and 868515.
Recalling Firm/
Manufacturer
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens, Florida 33410-4200
Manufacturer Reason
for Recall
Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a faxed letter. International customers were first notified by e-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Questions or concerns are directed to Kelly Taylor at the firm at 561-776-6700.
Quantity in Commerce 495 screws
Distribution Product was distributed to 3 distributors, 14 direct consumer/users. Product was distributed in Japan, Spain, Switzerland, Uruguay, Paraguay, Mexico, France, Netherlands, Australia, and in the US in KY, DC, IL, RI, MA, NJ and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DZL and Original Applicant = IMPLANT INNOVATIONS INTERNATIONAL, INC.
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