FDA Recall Terminated

Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.

Recall: Z-2296-2008 · Initiated July 7, 2008

Recall

Recall Number
Z-2296-2008
Event Number
48714
Firm
Zimmer Inc.
FEI Number
1000220733
Product Code
IKX
Status
Terminated
Root Cause
Device Design
Initiated
July 7, 2008
Posted
September 16, 2008
Terminated
November 12, 2009
Address
345 E Main St, Warsaw, IN, 46580-2746

Description

Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.

Reason

If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the patient in the bed, and the drop could present a laceration hazard by creating a sharp edge on the metal bar.

Action

Consignees were notified via recall letter dated 7/7/08 to discontinue use of these devices until the firm visits and replaces the devices. Contact Zimmer at 1-800-321-5533 for assistance.

Distribution

Nationwide and Canada.

Quantity

645 of all systems