Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shape
FDA device recall Z-2297-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IKX
- Quantity affected
- 645 of all systems
- Distribution
- Nationwide and Canada.
- Date initiated
- 2008-07-07
- Date posted
- 2008-09-16
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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