—#72457

Product

Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-2700-965-00 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.

FDA product code: IKX — Aid, Transfer
Device class: Class 1
Medical specialty: Physical Medicine
Affected lot / code info: All units shipped between 7/11/07 and 5/19/08.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2008-07-07
Posted by FDA: 2008-09-16
Terminated: 2009-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72457. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.