Date Initiated by Firm | July 27, 2009 |
Date Posted | May 14, 2010 |
Recall Status1 |
Terminated 3 on December 08, 2010 |
Recall Number | Z-1603-2010 |
Recall Event ID |
53197 |
Product Classification |
Non-Powered Orthopedic Traction Apparatus - Product Code HST
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Product | Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA |
Code Information |
lot numbers EN0001, EN0002. |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138-1400
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For Additional Information Contact | 408-754-2124 |
Manufacturer Reason for Recall | Latex-- Certain lots of Product contain undeclared latex. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | An Urgent: Device Removal notice, dated 7/27/2009 was sent to the sole distributor, Stryker Orthopaedics in New Jersey. The distributor will execute the sub-recall. The firm intends to scrap all returned product at that facility, who will provide a record of disposition. The distributor will notify consignees via a mail packet that will be sent via FedEx overnight mail. Consignees will be instructed to return all product to the distributor, with credit provided per policy. |
Quantity in Commerce | 842 units |
Distribution | Nationwide Distribution |
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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