***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC
FDA device recall Z-2634-2011 · posted 2011-06-23 · Terminated
Recall details
- Recalling firm
- RTI Biologics, Inc.
- Reason for recall
- RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this recall on 04/09/2011.
- Action taken
- RTI Biologics sent a "VOLUNTARY RECALL" letter dated April 9, 2008 to the one distributor, Spinal Graft Technologies. LLC. The letter describes the product, problem, and action to be taken by the distributor. The letter states that some of the product was issued a return authorization and requests that the distributor recover the remaining product from distribution. The recovered product will be issued a return authorization. RTI states the grafts can be returned in a non frozen state. Recall effectiveness will be determined by return of the product.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 26 units
- Distribution
- Domestic Distribution--TN only.
- Date initiated
- 2011-04-09
- Date posted
- 2011-06-23
- Date terminated
- 2012-07-24
- 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 |
|---|---|---|
| OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (K043420) | Regeneration Technologies, Inc. | 2005-02-10 |