Date Initiated by Firm | July 30, 2007 |
Date Posted | February 19, 2010 |
Recall Status1 |
Terminated 3 on February 19, 2010 |
Recall Number | Z-0795-2010 |
Recall Event ID |
50101 |
510(K)Number | K962152 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics.
Intended for cemented application to replace the articulating surface of the distal femur. |
Code Information |
Scorpio (no post) with LFIT: Product code 72-4107-L; Lot code: JKWMHD; |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
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For Additional Information Contact | Rita Intorella 201-831-5825 |
Manufacturer Reason for Recall | Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm.
For further information, contact Stryker Orthopaedics at (201) 831-5825. |
Quantity in Commerce | 7 |
Distribution | Worldwide Distribution -- United States and France. |
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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510(K) Database | 510(K)s with Product Code = JWH
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