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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Endoscopy PrepStrap Shoulder Sleeve

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  Class 2 Device Recall Stryker Endoscopy PrepStrap Shoulder Sleeve see related information
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
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
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
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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