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Terminated

Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA

FDA Recall Z-1603-2010 · Posted 2010-05-14

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHST
Date Initiated2009-07-27
Date Terminated2010-12-08
Product Quantity842 units

Reason for Recall

Latex-- Certain lots of Product contain undeclared latex.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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