FDA Recall Terminated

Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. Intended to provide the patient greater comfort and a sense of security.

Recall: Z-0943-2012 · Initiated October 31, 2011

Recall

Recall Number
Z-0943-2012
Event Number
60422
Firm
Stryker Medical Division of Stryker Corporation
FEI Number
1831750
Product Code
FPP
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
October 31, 2011
Posted
February 6, 2012
Terminated
August 28, 2013
Address
3800 East Centre Ave., Portage, MI, 49002

Description

Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. Intended to provide the patient greater comfort and a sense of security.

Reason

The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use.

Action

Stryker Medical spoke with all customers who received these shipments prior to 10/31/2011 requesting information on kits affected and recalled foot rest units installed. December 5, 2011 Urgent Medical Device Recall Letters, with instructions on how to to either install a new Foot Rest Kit ( enclosed ) or dispose of any kits that were not installed were sent to both customers who could have installed recalled foot rest units. Customers needing help or assistance with installation are asked to call Stryker Technical Support a 1-800-327-0770. Customers were to complete and return a postage paid postcard confirming receipt. Customers with questions or concerns are asked to contact Kristin Dudek at 269-389-6927 M-F m 8 a.m. - 5 p.m. (EST)

Distribution

Nationwide Distribution -- MI & MA.

Quantity

3 units