| Class 2 Device Recall Intramedullary Brush | |
Date Initiated by Firm | November 09, 2017 |
Create Date | March 28, 2018 |
Recall Status1 |
Terminated 3 on April 16, 2019 |
Recall Number | Z-1255-2018 |
Recall Event ID |
79418 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
Product | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853
for orthopedic use. |
Code Information |
Lot Number: 17284012 UDI: (01)4546540255853 |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
|
For Additional Information Contact | Erin Bissonnette 269-389-5330 |
Manufacturer Reason for Recall | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
FDA Determined Cause 2 | Environmental control |
Action | Letters dated November 16, 2017, were sent to customers.
Actions to be taken by the Customer/User:
1. Immediately review this Recall Notification.
2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility.
3. Quarantine and discontinue use of the recalled devices.
4. Complete and sign the enclosed Business Reply Form (BRF).
5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF.
6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email (erin.bissonnette@stryker.com).
7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account.
8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product. |
Quantity in Commerce | 320 |
Distribution | Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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.
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