Recall Z-2184-2020 ยท MQV Filler, Bone Void, Calcium Compound
Osteomed, LLC
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
| Date | May 29, 2020 (initiated Apr 2, 2020) |
| Status | Terminated |
| Reason | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Root cause | Vendor change control |
| Action | On 04/02/2020, an URGENT Medical Device Recall letter was sent to all consignees affected by the recall. OsteoMed has requested that affected customers: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or fax; and (2) return unused inventory via Federal Express (using OsteMed account) |
| Quantity | 436 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051123 | CALLOS IMPACT AND INJECT BONE VOID FILLER Skeletal Kinetics, LLC, Jun 3, 2005 |