REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void… recallZ-0939-2014 · RTI Surgical, Inc. · initiated Dec 6, 2013
Class II Terminated All recalls posted in February 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from RTI Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0939-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 6, 2013
- Posted by the FDA
- Feb 7, 2014
- Recalling firm
- RTI Surgical, Inc.
- Quantity
- 14 units
- Product code
- MQV
- FDA submissions
- K043421
- Distribution
- Distributed to Florida.
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.
Code information (models, lots, serial numbers)
Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.
Other devices under the same FDA submission
3 devices cleared under K043421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc 002530Rti Surgical, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
- OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc 002545Rti Surgical, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
- OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc 002590Rti Surgical, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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