Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.
FDA Recall Z-1546-2013 · Posted 2013-06-14
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeHST
Date Initiated2013-02-14
Date Terminated2014-05-01
Product Quantity344 Units
Reason for Recall
The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
Firm Action
Zimmer sent an Urgent Device Removal letter dated February 14, 2013, to all affected consignees. The letter identified the product, the problem,and the action to be taken by the consignee. Consignees were advised to review the notification letter, follow the instructions contained in the letter, remove from use and quarantine the affected product. Consignees were also instructed to complete and return the fax back from to 877-787-0375 or [email protected]. Consignees were instructed to return the affected product back using the shipping label provided. If affected product was further distribution, consignees were asked to provide the customer's information to the firm on the back of the form. For questions regarding this recall call 866-201-9081.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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