***REF 606-01-05***OPTEFORM Allograft Paste 5 cc — Class II medical device recall Z-0939-2014
Terminated recall by RTI Surgical, Inc., reported 2014-02-19, distributed in FL. RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc f
| Recall number | Z-0939-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc., Alachua, FL, United States |
| Recall initiated | 2013-12-06 |
| Classified | 2014-02-07 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-09-15 |
| Distributed | FL |
| Quantity | 14 units |
| Serial numbers | 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458, 8504459 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0939-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.