Date Initiated by Firm |
June 05, 2009 |
Date Posted |
August 04, 2009 |
Recall Status1 |
Terminated 3 on December 22, 2009 |
Recall Number |
Z-1701-2009 |
Recall Event ID |
52226 |
510(K)Number |
K032367
|
Product Classification |
orthopedic surgical instrument - Product Code HSB
|
Product |
Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00. |
Code Information |
Lots 60633223 and 60740476. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
800-371-8603
|
Manufacturer Reason for Recall |
Reamers labeled as having a standard diameter may actually be the dimensions of an Asia reamer, and vice versa.
|
FDA Determined Cause 2 |
Process control |
Action |
Zimmer sent an Urgent Device Recall letter dated 6/5/09 to all consignees and instructed to locate and return the products. |
Quantity in Commerce |
120 of both products |
Distribution |
Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand. |
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 = HSB and Original Applicant = ZIMMER, INC.
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