OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
- Company
- Osteomed, Llc
- Recall Initiated
- April 2, 2020
- Posted
- May 29, 2020
- Terminated
- May 5, 2021
- Recall Number
- Z-2188-2020
- Quantity
- 1724
- Firm Location
- Addison, TX
Reason for Recall
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.
Lot / Code Info
LOT 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043 and 1142210
Root Cause
Vendor change control
Action Taken
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)