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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.

FDA Recall Z-2296-2008 · Posted 2008-09-16

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeIKX
Date Initiated2008-07-07
Date Terminated2009-11-12
Product Quantity645 of all systems

Reason for Recall

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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