| Class 2 Device Recall TPS Drill | |
Date Initiated by Firm | January 10, 2008 |
Date Posted | April 22, 2008 |
Recall Status1 |
Terminated 3 on December 01, 2009 |
Recall Number | Z-1030-2008 |
Recall Event ID |
46341 |
510(K)Number | K032303 |
Product Classification |
bone cutting tool - Product Code HBE
|
Product | Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long "AM" attachments, sterile, Stryker Instruments, Kalamazoo, MI; REF 5230-107-530S1. |
Code Information |
All lots. |
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. 4056 |
Manufacturer Reason for Recall | Lack of assurance of sterility. |
FDA Determined Cause 2 | Package design/selection |
Action | Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email. |
Quantity in Commerce | 10,588 of all products |
Distribution | Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates. |
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 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 = HBE
|
|
|
|