Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0943-2012

Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631...

Stryker Medical / initiated 2011-10-31 / Terminated

Stryker Medical Division of Stryker Corporation began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0943-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
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.
Product code
FPP Stretcher, Hand-Carried
Reason for recall
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.
FDA root cause
Mixed-up of materials/components
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)
Quantity in commerce
3 units
Distribution
Nationwide Distribution -- MI & MA.
Product codes and lots
Model 6251 and 6252, The Foot Rest Kit (pN 6252-700-003) Order numbers 2065939, 1739631, 2066066, 2066803, and 2066941.