Home / Recalls / RTI Surgical, Inc. / Z-0939-2014

Z-0939-2014 Class II Terminated

Recalled by RTI Surgical, Inc. — Alachua, FL

Recall Details

Product Type: Devices
Report Date: February 19, 2014
Initiation Date: December 6, 2013
Termination Date: September 15, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14 units

Product Description

***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.

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.

Distribution Pattern

Distributed to Florida.

Code Information

Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.