Date Initiated by Firm |
January 10, 2008 |
Date Posted |
May 01, 2008 |
Recall Status1 |
Terminated 3 on July 31, 2008 |
Recall Number |
Z-1106-2008 |
Recall Event ID |
46340 |
Product Classification |
bone cement accessory - Product Code JDZ
|
Product |
Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001. |
Code Information |
Lot Numbers: 05167CG2, 05192012, 05223012 and 06335012. |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E. Milham Ave. Portage MI 49002-9704
|
For Additional Information Contact |
800-800-4236 Ext. 3808
|
Manufacturer Reason for Recall |
Sterility may be compromised, as the packaging may have channels in the packaging seal.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it. |
Quantity in Commerce |
25 boxes of 6 each |
Distribution |
Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming. |
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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