Z-0939-2014Class II

REF 606-01-05OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic...

Name: Z-0939-2014 ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic...
Creator: RTI Surgical, Inc.
Published: 2013-12-06
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2013-12-06 / Terminated

FDA source

RTI Surgical, Inc. began a recall of ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx... on 2013-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0939-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-06
Posted: 2014-02-07
Terminated: 2014-09-15
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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.
Product code: MQV Filler, Bone Void, Calcium Compound
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 root cause: 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.
Product codes and lots: Serial Numbers: 8504395, 8504396, 8504397, 8504398, 8504399, 8504450, 8504452, 8504453, 8504454, 8504455, 8504456, 8504457, 8504458 and 8504459.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0939-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0939-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-07

Product code MQV

K043421Class IIOpteform, Osteofil, Rti Allograft Paste Ic, Rti Allograft Strip IcRegeneration Technologies, Inc. / cleared 2005-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)