| Date Initiated by Firm |
December 16, 2019 |
| Create Date |
January 29, 2020 |
| Recall Status1 |
Terminated 3 on June 08, 2020 |
| Recall Number |
Z-0879-2020 |
| Recall Event ID |
84593 |
| 510(K)Number |
K103243
|
| Product Classification |
Plate, fixation, bone - Product Code HRS
|
| Product |
2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. |
| Code Information |
Lot Number: 6L37877 |
Recalling Firm/
Manufacturer |
Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
|
| For Additional Information Contact |
Mona Rehmatullah
561-494-3036
|
Manufacturer Reason
for Recall |
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
An Urgent Medical Device Correction notification letter dated 12/16/19 was distributed to customers.
Instructions to follow:
To reduce the possibility of the inner cap coming loose or the inner tube remaining in the outer tube while removing the outer cap follow these techniques:
" Option 1: Suggested opening technique for all affected lots
1. When opening the outer tube, ensure that the inner cap and inner tube are intact and turning freely in the outer tube
2. If the inner cap is not turning freely, push the outer cap towards the tube and keep turning counter-clockwise until you see the inner tube and the inner cap turning in the outer tube (remove the labels to increase visibility).
3. Once you see that the inner cap is turning in the outer tube then pull out the outer cap with the inner tube and inter cap intact. Hold the outer cap at an upward angle as you separate the outer cap from the outer tube.
4. Continue as usual by following steps 4-6 in the Sterile Tube User Guide (DSUS/TRM/1216/1243).
Option 2: If Option 1 does not work
1. Reject the screw and use a replacement sterile tube, blister or non-sterile variant, depending on availability.
2. Please ensure a product complaint is filed and product returned for the issue according to your local procedure.
Actions to be taken:
Our records show that your facility has received products that are subject to this field safety notification. We ask that you review the information contained in this notification and complete the Verification Section located on page 4 of this letter.
Please take the following actions:
" Review the instructions listed in this notification.
" Forward this notice to anyone in your facility that needs to be informed.
" If any of the subject product has been forwarded to another facility, contact that facility.
" Keep a copy of this notice with the subject product.
" Review, complete, sign, and return the Verification Section (page 4 of this letter) to your local sales |
| Quantity in Commerce |
25 total |
| Distribution |
US Nationwide distribution in the states of AL and ID. |
| 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 = HRS and Original Applicant = SYNTHES (USA)
|
