| Date Initiated by Firm |
June 01, 2003 |
| Date Posted |
July 29, 2003 |
| Recall Status1 |
Terminated 3 on November 13, 2003 |
| Recall Number |
Z-0921-03 |
| Recall Event ID |
26415 |
| 510(K)Number |
K912190
|
| Product |
Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000. |
| Code Information |
lot 03030232. |
Recalling Firm/
Manufacturer |
Stryker Instruments, Instruments Div.
4100 E. Milham
Kalamazoo MI 49001
|
| For Additional Information Contact |
Dannielle Wheeler
800-800-4236 Ext. 7666
|
Manufacturer Reason
for Recall |
Non-sterilized product sold as sterile.
|
FDA Determined
Cause 2 |
Other |
| Action |
Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail |
| Quantity in Commerce |
440 boxes |
| Distribution |
United States, Canada, Italy, Japan and United Kingdom |
|
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 = and Original Applicant = STRYKER CORP.
|
