Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc Recalled by RTI Surgical, Inc. Due to RTI Surgical, Inc. of Alachua, FL is recalling...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RTI Surgical, Inc. directly.
Affected Products
***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.
Quantity: 14 units
Why Was This Recalled?
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.
Where Was This Sold?
Distributed to Florida.
About RTI Surgical, Inc.
RTI Surgical, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report