***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications
FDA device recall Z-0939-2014 · posted 2014-02-07 · Terminated
Recall details
- Recalling firm
- RTI Surgical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 14 units
- Distribution
- Distributed to Florida.
- Date initiated
- 2013-12-06
- Date posted
- 2014-02-07
- Date terminated
- 2014-09-15
- Location
- Alachua, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC (K043421) | Regeneration Technologies, Inc. | 2005-02-16 |