Recall Z-0943-2012 ยท FPP Stretcher, Hand-Carried
Stryker Medical Division of Stryker Corporation
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.
| Date | Feb 6, 2012 (initiated Oct 31, 2011) |
| Status | Terminated |
| 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. |
| 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 p |
| Quantity | 3 units |
| Distribution | Nationwide Distribution -- MI & MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.