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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Zimmer Inc.
- Recall Initiated
- July 7, 2008
- Posted
- September 16, 2008
- Terminated
- November 12, 2009
- Recall Number
- Z-2298-2008
- Quantity
- 645 of all systems
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Canada.
Lot / Code Info
All units shipped between 7/11/07 and 5/19/08.
Root Cause
Device Design
Action Taken
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.
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