Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and tra

FDA device recall Z-0629-2013 · posted 2013-01-03 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.

Action taken

Stryker sent an Urgent Medical Device Correction letterdated December 18, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate the affected product and ensure that the brakes are holding properly. Consignees were directed to contact Stryker (1-800-327-0770, option 2) to make arrangements to replace all brake rings and continue to routinely inspect brake functionality. Customers were asked to Fax (269-488-8691) the enclosed acknowledgment and Stryker field service will contact customers to schedule service. Consignees were directed to forward a copy of this notice to the new users and advise us of their new location. For questions regarding this recall call 269-488-8691.

Root cause

Process control

Status

Terminated

Product code

FNL

Quantity affected

1004

Distribution

Worldwide Distribution - Nationwide and Canada

Date initiated

2012-12-18

Date posted

2013-01-03

Date terminated

2013-08-30

Location

Portage, MI