Recall Z-1097-2016 ยท NPM Bone Grafting Material, Animal Source
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
| Date | Mar 11, 2016 (initiated May 13, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS Collagen Matrix, Inc., Aug 4, 2005 |