| Date Initiated by Firm | November 20, 2013 |
|---|
| Date Posted | December 26, 2013 |
|---|
| Recall Status1 |
Terminated 3 on September 06, 2018 |
| Recall Number | Z-0573-2014 |
|---|
| Recall Event ID |
66914 |
| 510(K)Number | K121060 |
|---|
| Product Classification |
Appliance, fixation, spinal intervertebral body - Product Code KWQ
|
| Product | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered.
Used to secure the Invue Anterior Cervical Plate in position. |
|---|
| Code Information |
Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000 |
Recalling Firm/
Manufacturer |
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
|
| For Additional Information Contact | Bill Conlon
978-232-3990 |
|---|
Manufacturer Reason
for Recall | Mismarked and unmarked screws |
|---|
FDA Determined
Cause 2 | Packaging process control |
|---|
| Action | On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email. |
|---|
| Quantity in Commerce | 993 |
|---|
| Distribution | Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI. |
|---|
| 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 = KWQ
|
|---|
