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U.S. Department of Health and Human Services

Class 3 Device Recall 2.0x7mm Fossa Xdrive screws

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 Class 3 Device Recall 2.0x7mm Fossa Xdrive screwssee related information
Date Initiated by FirmJune 25, 2010
Date PostedJuly 11, 2011
Recall Status1 Terminated 3 on November 09, 2011
Recall NumberZ-2779-2011
Recall Event ID 59100
Product Classification Screw, oral - Product Code KBW
ProductLabeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA SCREW 5/PKG***2.0 MM X 7.0 MM***". Bone screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. These screws are to be used with our TMJ (Temporal Mandibular Joint) implants.
Code Information Lot # 233270
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information ContactChristy Cain
904-741-4400
Manufacturer Reason
for Recall		Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5 pack, lot # 233270. This product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm Fossa x-drive screws, 5 pack.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionBiomet Microfixation, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an Inventory Reconciliation form via fax to 904-741-9425. The form requests that customers indicate whether they want to keep the product or return for credit. Customers can contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400 ext. 468 for questions regarding this recall.
Quantity in Commerce25 units
DistributionProduct was distributed to one distributor in Argentina.
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.
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