FDA Medical Device Recalls (openFDA)
Collagen Matrix Inc: 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
- Recall number
- Z-1097-2016
- Recalling firm
- Collagen Matrix Inc
- 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
- Status
- Terminated
- Initiated
- 2013-05-13
- Posted
- 2016-03-11
- Terminated
- 2017-06-21
- Reason
- 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.
- Root cause
- 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
- 347 units
- Distribution
- US Distribution to state of: MA.
- Lot, serial or model codes
- Lot BMCXU11P1. BMCXU11H3 Lot BMCXU11P1, BMCXU12P1
- 510(k) numbers
- ["K043034"]
- PMA numbers
- not on file
- Product code
- NPM
- Firm FEI
- 3003300673
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28