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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm August 07, 2023
Date Posted September 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-2596-2023
Recall Event ID 92841
510(K)Number K931847  
Product Classification Cement obturator - Product Code LZN
Product Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
Code Information GTIN: 04546540039415 Lot Numbers: 22314012 22336012
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 109 units US; 290 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 and Original Applicant = BIO MEDICAL DEVICES, INC.
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