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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Void Filler

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  Class 2 Device Recall Bone Void Filler see related information
Date Initiated by Firm April 02, 2020
Date Posted May 29, 2020
Recall Status1 Terminated 3 on May 05, 2021
Recall Number Z-2186-2020
Recall Event ID 85529
510(K)Number k100986  
Product Classification Filler, bone void, calcium compound - Product Code MQV
Product OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Code Information LOT 17102713, 1156491, 17051907, 1136327 and 1126984  
Recalling Firm/
Manufacturer		 Osteomed, LLC
3885 Arapaho Rd
Addison TX 75001-4314
For Additional Information Contact Ms. Kathryn Jayne
972-677-4766
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 153
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = SKELETAL KINETICS, LLC
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