Recall Z-1603-2010 ยท HST Apparatus, Traction, Non-Powered
Stryker Endoscopy
Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA
| Date | May 14, 2010 (initiated Jul 27, 2009) |
| Status | Terminated |
| Reason | Latex-- Certain lots of Product contain undeclared latex. |
| Root cause | 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 | 842 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.