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U.S. Department of Health and Human Services

Class 2 Device Recall OPTEFORM Allograft Paste

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  Class 2 Device Recall OPTEFORM Allograft Paste see related information
Date Initiated by Firm December 06, 2013
Date Posted February 07, 2014
Recall Status1 Terminated 3 on September 15, 2014
Recall Number Z-0939-2014
Recall Event ID 67246
510(K)Number K043421  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
Code Information Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.
Recalling Firm/
Manufacturer		 RTI Surgical, Inc.
11621 Research Cir
Alachua FL 32615-6825
For Additional Information Contact Wendy Crites Wacker
386-418-8888 Ext. 4806
Manufacturer Reason
for Recall		 RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
FDA Determined
Cause 2		 Other
Action RTI Surgical issued a: URGENT: Medical Device Recall Notification dated December 6, 2013 to their customer. The customer was instructed to quarantine the product immediately and return to RTI Surgical, Inc. for final disposition. For questions or concerns, call 386-418-8888.
Quantity in Commerce 14 units
Distribution Distributed to Florida.
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 = MQV and Original Applicant = REGENERATION TECHNOLOGIES, INC.
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