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U.S. Department of Health and Human Services

Class 2 Device Recall NuOss XC Sinus

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  Class 2 Device Recall NuOss XC Sinus see related information
Date Initiated by Firm May 13, 2013
Date Posted March 11, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-1097-2016
Recall Event ID 73206
510(K)Number K043034  
Product Classification Bone grafting material, animal source - Product Code NPM
Product NuOss 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
Recalling Firm/
Manufacturer		 Collagen Matrix Inc
509 Commerce St
Franklin Lakes NJ 07417-1374
For Additional Information Contact Ms. 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
Action The 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 Commerce 347 units
Distribution US Distribution to state of: MA.
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 = NPM and Original Applicant = COLLAGEN MATRIX, INC.
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