| Date Initiated by Firm | July 07, 2017 |
|---|
| Create Date | January 10, 2018 |
|---|
| Recall Status1 |
Terminated 3 on October 15, 2019 |
| Recall Number | Z-0325-2018 |
|---|
| Recall Event ID |
77991 |
| 510(K)Number | K153152 |
|---|
| Product Classification |
Thoracolumbosacral pedicle screw system - Product Code NKB
|
| Product | Mac Pin Non-Cannulated Screw, 6.5 x 60mm |
|---|
| Code Information |
Model #85-6560-1, Lot #132117 |
| FEI Number |
3007970248
|
Recalling Firm/
Manufacturer |
Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
|
| For Additional Information Contact |
770-575-5224 |
|---|
Manufacturer Reason
for Recall | Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224. |
|---|
| Quantity in Commerce | 41 screws |
|---|
| Distribution | Distribution to Georgia, USA. |
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| 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 = NKB
|
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