Recall Z-1526-2020 ยท MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
XTANT MEDICAL INC
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for
| Date | May 3, 2019 |
| Status | Terminated |
| Reason | The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled. |
| Root cause | Labeling Change Control |
| Action | On May 3, 2019 a customer letter (in an envelope marked URGENT) was Federal Expressed overnight-signature required to the 16 customers who received the 26 devices. The specific actions to be taken by the customer/user that were shipped the product affected by the recall are requested to do the following: 1. Immediately examine their inventory and quarantine any affected products subject to this recall. 2. Complete an enclosed Acknowledgement Form, even if they have no remaining devices in their inventory, and return the completed Acknowledgment Form via mail: Mail: DBM Recall 664 Cruiser |
| Quantity | 26 |
| Distribution | US Nationwide Distribution in the states of AZ,CA, NC, NJ, NY, PA, SC, TX, and WA. There were no OUS consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY Bacterin International, Inc., May 31, 2013 |