Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA
FDA device recall Z-1603-2010 · posted 2010-05-14 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Latex-- Certain lots of Product contain undeclared latex.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HST
- Quantity affected
- 842 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-07-27
- Date posted
- 2010-05-14
- Date terminated
- 2010-12-08
- Location
- San Jose, CA
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