NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22
FDA device recall Z-1097-2016 · posted 2016-03-11 · Terminated
Recall details
- Recalling firm
- Collagen Matrix Inc
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NPM
- Quantity affected
- 347 units
- Distribution
- US Distribution to state of: MA.
- Date initiated
- 2013-05-13
- Date posted
- 2016-03-11
- Date terminated
- 2017-06-21
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS (K043034) | Collagen Matrix, Inc. | 2005-08-04 |