Date Initiated by Firm | August 07, 2023 |
Date Posted | September 19, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2600-2023 |
Recall Event ID |
92841 |
510(K)Number | K931847 |
Product Classification |
Cement obturator - Product Code LZN
|
Product | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process
Catalog Number: 0306-573-000 |
Code Information |
GTIN: 04546540055415
Lot Numbers:
22313012
22314012
22315012
22343012
22348012
22349012
22350012
22353012
|
Recalling Firm/ Manufacturer |
Stryker Corporation 1941 Stryker Way Portage MI 49002-9711
|
For Additional Information Contact | same 269-800-1941 |
Manufacturer Reason for Recall | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Stryker issued Urgent Medical Device Recall letter on 8/07/23. Letter states reason for recall, health risk and action to take:
Actions needed
1. Immediately review your inventory to locate and quarantine any affected
products at your facility.
2. Return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com.
3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand.
4. A replacement order will be shipped to customers upon receipt of the recalled product.
5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly.
If you have any questions about this matter, contact Stryker Instruments by email at Instruments.Recalls@stryker.com. |
Quantity in Commerce | 652 units US; 1607 units OUS |
Distribution | Nationwide
Foreign:
Austria
Belgium
Canada
France
Germany
Hong Kong
Italy
Malaysia
Poland
Singapore
South Korea
Spain
Taiwan
Thailand
UK
|
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = LZN
|