| Date Initiated by Firm | August 25, 2015 |
|---|
| Create Date | March 11, 2016 |
|---|
| Recall Status1 |
Terminated 3 on May 11, 2016 |
| Recall Number | Z-1096-2016 |
|---|
| Recall Event ID |
73222 |
| 510(K)Number | K043034 |
|---|
| Product Classification |
Bone grafting material, animal source - Product Code NPM
|
| Product | NuOSS Cancellous
Intended for use in dental surgery. |
|---|
| Code Information |
Reference No. BM2C20010-U Lot no. BM2CU15E2 |
| FEI Number |
3003300673
|
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 | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size. |
|---|
FDA Determined
Cause 2 | Unknown/Undetermined by firm |
|---|
| Action | Collagen Matrix Inc. notified their sole customer on November 17, 2015.
On August 25, 2015, during a review of inventory, tt was discovered that of the 171 units product shipped, 19 units may have been the incorrect size.
For further questions please call (201) 405-1477 |
|---|
| Quantity in Commerce | 171 units |
|---|
| Distribution | US Distribution to the 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
|
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