Date Initiated by Firm | June 26, 2009 |
Date Posted | September 14, 2009 |
Recall Status1 |
Terminated 3 on July 27, 2010 |
Recall Number | Z-2133-2009 |
Recall Event ID |
52713 |
510(K)Number | K873251 |
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product | Stryker Orthopaedics Bone Screw;
Dia 6.5 mm; Lnth: 30 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that may be used during knee and hip replacement procedures. |
Code Information |
Catalog number: 2020-6530-1; Lot number HRKMME, Exp. 8/20/2013. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact | Colleen O'Meara 201-972-2100 |
Manufacturer Reason for Recall | Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069.
For further information, contact Stryker Orthopaedics at 1-201-831-5970. |
Quantity in Commerce | 51,113 total - all sizes. |
Distribution | Worldwide Distribution |
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 = HWC
|