Recalls / —

—#84913

Product

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

FDA product code

HST — Apparatus, Traction, Non-Powered

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

lot numbers EN0001, EN0002.

Why it was recalled

Latex-- Certain lots of Product contain undeclared latex.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Stryker Endoscopy

Address

5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2009-07-27

Posted by FDA

2010-05-14

Terminated

2010-12-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #84913. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.