Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NuOss XC Sinus

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall NuOss XC Sinussee related information
Date Initiated by FirmMay 13, 2013
Date PostedMarch 11, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall NumberZ-1097-2016
Recall Event ID 73206
510(K)NumberK043034 
Product Classification Bone grafting material, animal source - Product Code NPM
ProductNuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
Code Information Lot BMCXU11P1. BMCXU11H3  Lot BMCXU11P1, BMCXU12P1
FEI Number 3003300673
Recalling Firm/
Manufacturer		 Collagen Matrix Inc
509 Commerce St
Franklin Lakes NJ 07417-1374
For Additional Information ContactMs. Peggy Hansen
201-405-1477
Manufacturer Reason
for Recall		During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
FDA Determined
Cause 2		Process control
ActionThe firm, Collagen Matrix Inc., sent an email dated May 14, 2013 to its sole customer. The email described the product, problem and actions to be taken. The customer was instructed to return all product with expiration dates 12/2014 or earlier under Returned Goods, the firm will replace these products with new inventory; and return to Collagen Matrix, Inc., 15 Thornton Road, Oakland, NJ 07436 or quarantine products with expiration date 1/2016 until further notice. If you have any questions,call 201-405-1477 x 304 or email: www.collagenmatrix.com.
Quantity in Commerce347 units
DistributionUS Distribution to state of: MA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NPM
-
-